Latest Dupixent (Dupilumab) and Itepekimab Data at ERS Highlight Scientific Innovation and Leadership in Respiratory Diseases
Latest Dupixent (Dupilumab) and Itepekimab Data at ERS Highlight Scientific Innovation and Leadership in Respiratory Diseases
20 abstracts, including 4 oral presentations, offer new treatment insights for chronic obstructive pulmonary disease (COPD), asthma and chronic rhinosinusitis with nasal polyps (CRSwNP)
20 份摘要,包括 4 份口頭報告,爲慢性阻塞性肺病 (COPD)、哮喘和伴有鼻息肉的慢性鼻竇炎 (crsWnP) 提供了新的治療見解
Data from landmark Phase 3 trials for Dupixent in COPD reinforce exacerbation reduction and improvement in lung function compared to placebo, and provide new assessments on health-related quality of life across patient subgroups
與安慰劑相比,來自Dupixent治療慢性阻塞性肺病的具有里程碑意義的3期試驗的數據可增強惡化的減少和肺功能的改善,併爲患者亞組的健康相關生活質量提供了新的評估
Additional presentations spotlight a novel asthma imaging study showing the early impact of Dupixent on clinical remission, airway remodeling and mucus plugging starting at 4 weeks, as well as data from investigational therapy itepekimab in former smokers with COPD
其他演講重點介紹了一項新的哮喘成像研究,該研究顯示了從4周開始Dupixent對臨床緩解、氣道重塑和粘液堵塞的早期影響,以及研究性療法依培基單抗對前慢性阻塞性肺病吸菸者的數據
TARRYTOWN, N.Y., Aug. 26, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced 20 abstracts across Dupixent (dupilumab) and investigational therapy itepekimab will be presented at the European Respiratory Society (ERS) Congress 2024 being held from September 7 to 11 in Vienna, Austria. These clinical and real-world abstracts presented in collaboration with Sanofi include four oral presentations and demonstrate the potential of targeting key drivers of type 2 inflammation and other pathways to address respiratory diseases, such as COPD and asthma, and improve patient outcomes.
紐約州塔裏敦,2024年8月26日(GLOBE NEWSWIRE)——Regeneron Pharmicals, Inc.(納斯達克股票代碼:REGN)今天宣佈,關於Dupixent(dupilumab)和研究療法依培基單抗的20份摘要將在9月7日至11日在奧地利維也納舉行的2024年歐洲呼吸學會(ERS)大會上發表。這些與賽諾菲合作發佈的臨床和現實世界摘要包括四份口頭報告,展示了靶向2型炎症的關鍵驅動因素和其他途徑來解決慢性阻塞性肺病和哮喘等呼吸系統疾病和改善患者預後的潛力。
"The breadth of our presentations at the ERS Congress showcase our commitment to advancing the management of a range of difficult-to-treat respiratory diseases," said George D. Yancopoulos, M.D., Ph.D., Board co-Chair, President and Chief Scientific Officer at Regeneron, and a principal inventor of Dupixent. "Through our Dupixent clinical program, we have gained a deep understanding of the biology of airway diseases. We are now applying those insights to COPD, a complex and heterogenous disease, and are excited by the remarkable potential of our COPD research program investigating Dupixent, as well as our anti-IL-33 antibody itepekimab to support COPD patients regardless of smoking history."
Regeneron董事會聯席主席、總裁兼首席科學官、Dupixent的主要發明者喬治·揚科普洛斯萬博士說:「我們在ERS大會上的廣泛演講表明了我們對推進一系列難以治療的呼吸系統疾病管理的承諾。」「通過我們的Dupixent臨床項目,我們對氣道疾病的生物學有了深刻的了解。現在,我們正在將這些見解應用於慢性阻塞性肺病,這是一種複雜的異源性疾病,我們研究Dupixent的慢性阻塞性肺病研究項目的巨大潛力以及我們的抗IL-33抗體itepekimab可以爲慢性阻塞性肺病患者提供支持,無論吸菸史如何。」
Among the notable Dupixent presentations at ERS is a pooled analysis of the previously reported Phase 3 BOREAS and NOTUS trials in uncontrolled COPD with evidence of type 2 inflammation (i.e., raised blood eosinophils). In the trials, all patients were on background maximal standard-of-care inhaled therapy (with nearly all on triple therapy). BOREAS and NOTUS formed the basis of the recent European Commission approval and regulatory submissions around the world for Dupixent in certain patients with uncontrolled COPD.
Dupixent在ERS的引人注目的表現之一是對先前報告的非控制慢性阻塞性肺病的3期BOREAS和NOTUS試驗的合併分析,這些試驗有2型炎症(即血液中嗜酸性粒細胞升高)的證據。在試驗中,所有患者都接受了最高護理標準的吸入療法(幾乎所有患者都接受了三聯療法)。BOREAS和NOTUS構成了歐盟委員會最近在全球範圍內批准Dupixent用於某些不受控制的慢性阻塞性肺病患者的批准和監管申報的基礎。
As shared in the abstract, the pooled analysis demonstrated that Dupixent patients (n=938) experienced a 31% reduction in the annualized rate of moderate or severe COPD exacerbations over 52 weeks compared to placebo (n=936; nominal p<0.0001). Additional COPD data to be presented at the meeting will evaluate the impact of Dupixent on daily symptom frequency and severity, exacerbations and lung function regardless of baseline body mass index, airflow obstruction, dyspnea (shortness of breath) and exercise capacity measures. Safety results were generally consistent with the known safety profile of Dupixent in its approved indications. Adverse events more commonly observed with Dupixent (≥5%) compared to placebo in either COPD trial were back pain, COVID-19, diarrhea, headache and nasopharyngitis.
如摘要中所述,合併分析表明,與安慰劑相比,Dupixent患者(n=938)在52周內中度或重度慢性阻塞性肺病的年化發作率降低了31%(n=936;名義p
Additionally, new research will be shared from the Phase 4 VESTIGE trial, a novel imaging study evaluating the effects of Dupixent on airway remodeling in certain adults with asthma. Two poster presentations will show new data on the 4-week impact of Dupixent treatment on airway inflammation, volume, and flow, and mucus plugging, as well as outcomes for clinical remission after 4 and 24 weeks of treatment in adults with uncontrolled moderate-to-severe asthma.
此外,將分享4期VESTIGE試驗的新研究,這是一項新的影像學研究,評估了Dupixent對某些哮喘成年人氣道重塑的影響。兩張海報演示將展示有關Dupixent治療對氣道炎症、體積和氣流以及粘液堵塞的4周影響的新數據,以及未受控制的中度至重度哮喘成人治療4周和24周後的臨床緩解結果。
The full list of Regeneron and Sanofi presentations at ERS includes:
Regeneron 和 Sanofi 在 ERS 上的完整演講清單包括:
Abstract title |
Abstract |
Presenting |
Presentation |
COPD | |||
Reduction in exacerbations with itepekimab in former smokers with chronic obstructive pulmonary disease (COPD) by prior exacerbation frequency |
OA3645 Oral |
Rabe, K.F. |
Monday, |
Dupilumab Efficacy and Safety in Patients with Moderate-to-Severe COPD with Type 2 Inflammation: Pooled Analysis of BOREAS and NOTUS Trials |
PA4787 |
Bhatt, S. |
Tuesday, |
Dupilumab improves respiratory symptoms in patients with moderate-to-severe COPD with type 2 inflammation in phase 3 BOREAS trial |
PA4786 |
Papi, A. |
Tuesday, |
Dupilumab improves quality of life in non-exacerbators with moderate-to-severe COPD and type 2 inflammation: phase 3 BOREAS trial |
PA4784 |
Rabe, K.F. |
Tuesday, |
Dupilumab improves lung function in non-exacerbators with moderate-to-severe COPD with type 2 inflammation in phase 3 BOREAS trial |
PA4785 |
Rabe, K.F. |
Tuesday, |
Dupilumab efficacy in patients with COPD and type 2 inflammation irrespective of mortality risk |
PA4782 |
Vogelmeier, C. |
Tuesday, |
Asthma | |||
Clinical remission with dupilumab in children with uncontrolled, moderate-to-severe, type 2 asthma (dupilumab) |
RCT3719 |
Bacharier, L. |
Monday, |
Impact of early transient increase in eosinophils in patients with moderate-to-severe asthma on the long-term efficacy of dupilumab in TRAVERSE |
OA2779 Oral |
Pavord, I. |
Monday, |
Dupilumab reduces mucus plugging and volume: phase 4 VESTIGE trial |
OA3649 Oral |
Porsberg, C. |
Monday, |
Effectiveness of dupilumab vs omalizumab in patients with severe asthma – The EU-ADVANTAGE |
PA2171 |
Canonica, |
Monday, |
Characteristics of long-term oral corticosteroid users stratified by blood eosinophil count in the International Severe Asthma Registry |
PA439 Poster |
Chan, J. |
Sunday, |
Phenotype and biomarkers in patients who initiated biologic therapy stratified by oral corticosteroids use in the International Severe Asthma Registry |
PA438 Poster |
Chan, J. |
Sunday, |
Dupilumab-treated patients with moderate-to-severe asthma are more likely to meet clinical remission criteria: results from the VESTIGE trial |
PA1202 |
Lugogo, N.L. |
Sunday, |
Baseline Characteristics of Patients with Asthma Initiating Dupilumab in a Real-World Setting: the RAPID Registry |
PA4484 |
Lugogo, N.L. |
Tuesday, |
Early treatment response to dupilumab on airway inflammation, airway dynamics, and mucus plugging in VESTIGE |
PA3933 |
Papi, A. |
Tuesday, |
Real-world effectiveness of dupilumab vs benralizumab and vs mepolizumab in severe asthma: The EU-ADVANTAGE study |
PA2170 |
Virchow, J.C. |
Monday, |
Dupilumab improves lung function and reduces exacerbations despite withdrawal of inhaled corticosteroids/long-acting beta agonists |
PA1172 Late- |
Wechsler, M.E. |
Sunday, |
Dupilumab Reduces Exacerbations and FeNO Levels and Improves Asthma Control with Inhaled Corticosteroid Withdrawal: a Phase 2 Study |
PA5371 |
Wechsler, M.E. |
Tuesday, |
CRSwNP | |||
Baseline Characteristics of Patients with Chronic Rhinosinusitis with Nasal Polyps and Coexisting Asthma Initiating Dupilumab in the AROMA Global Registry |
PA425 Poster |
Heffler, E. |
Sunday, |
Initiation of dupilumab led to reduced use of oral corticosteroids (OCS) and other medications over 12 months in patients with chronic rhinosinusitis with nasal polyps (CRSwNP): A US real-world practice study |
PA2177 |
Lee, S.E. |
Monday, |
摘要標題 |
摘要 |
呈現 |
演示 |
慢性阻塞性 | |||
根據先前的加重頻率,使用依培基單抗可減少患有慢性阻塞性肺病(COPD)的前吸菸者的加重情況 |
OA3645 口服 |
Rabe萬.F。 |
星期一, |
Dupilumab對伴有2型炎症的中度至重度慢性阻塞性肺病患者的療效和安全性:BOREAS和NOTUS試驗的合併分析 |
PA4787 |
巴特,S. |
星期二, |
在BOREAS的3期試驗中,Dupilumab改善了伴有2型炎症的中度至重度慢性阻塞性肺病患者的呼吸道症狀 |
PA4786 |
爸爸,A. |
星期二, |
Dupilumab改善了患有中度至重度慢性阻塞性肺病和2型炎症的非惡化劑的生活質量:BOREAS的3期試驗 |
PA4784 |
Rabe萬.F。 |
星期二, |
在3期BOREAS試驗中,Dupilumab改善了伴有2型炎症的中度至重度慢性阻塞性肺病的非惡化劑的肺功能 |
PA4785 |
Rabe萬.F。 |
星期二, |
無論死亡風險如何,Dupilumab對慢性阻塞性肺病和2型炎症患者的療效 |
PA4782 |
沃格爾邁爾,C. |
星期二, |
哮喘 | |||
dupilumab 對未受控制、中度至重度 2 型哮喘(dupilumab)患兒的臨床緩解 |
RCT3719 |
Bacharier,L. |
星期一, |
中度至重度哮喘患者嗜酸性粒細胞的早期短暫性增加對杜普魯單抗在TRAVERSE中的長期療效的影響 |
OA2779 口服 |
帕沃德,I. |
星期一, |
Dupilumab 可減少粘液堵塞和體積:4 期 VESTIGE 試驗 |
OA3649 口服 |
波爾斯伯格,C. |
星期一, |
dupilumab與奧馬珠單抗對重度哮喘患者的有效性——歐盟優勢 |
PA2171 |
卡諾尼卡, |
星期一, |
長期口服皮質類固醇使用者的特徵,按國際重度哮喘登記處血液嗜酸粒細胞計數進行分層 |
PA439 海報 |
陳,J. |
星期日, |
國際重度哮喘登記處開始生物治療的患者的表型和生物標誌物(按口服皮質類固醇的使用進行分層) |
PA438 海報 |
陳,J. |
星期日, |
接受Dupilumab治療的中度至重度哮喘患者更有可能達到臨床緩解標準:VESTIGE試驗的結果 |
PA1202 |
盧戈戈,N.L. |
星期日, |
哮喘患者在現實環境中啓動杜匹魯單抗的基線特徵:RAPID 註冊表 |
PA4484 |
盧戈戈,N.L. |
星期二, |
對dupilumab的早期治療對氣道炎症、氣道動力學和VESTIGE粘液堵塞的反應 |
PA3933 |
爸爸,A. |
星期二, |
dupilumab 與 benralizumab 和對比 mepolizumab 在嚴重哮喘中的實際療效:EU-ADVANTAGE 研究 |
PA2170 |
Virchow,J.C. |
星期一, |
儘管停用了吸入性皮質類固醇/長效β激動劑,但Dupilumab仍能改善肺功能並減少惡化 |
PA1172 Late- |
Wechsler萬.E。 |
星期日, |
Dupilumab 可通過吸入性皮質類固醇戒斷來降低病情加重和 FeNO 水平並改善哮喘控制:一項 2 期研究 |
PA5371 |
Wechsler萬.E。 |
星期二, |
crsWnp | |||
伴有鼻息肉和哮喘的慢性鼻竇炎患者的基線特徵在AROMA全球註冊中啓動dupilumab |
PA425 海報 |
赫夫勒,E. |
星期日, |
dupilumab的啓動使伴有鼻息肉的慢性鼻竇炎(crsWnP)患者在12個月內減少了口服皮質類固醇(OCS)和其他藥物的使用:一項美國現實世界實踐研究 |
PA2177 |
Lee,S.E. |
星期一, |
About Dupixent
Dupixent, which was invented using Regeneron's proprietary VelocImmune technology, is a fully human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways and is not an immunosuppressant. The Dupixent development program has shown significant clinical benefit and a decrease in type 2 inflammation in Phase 3 trials, establishing that IL-4 and IL-13 are key and central drivers of the type 2 inflammation that plays a major role in multiple related and often co-morbid diseases.
關於 Dupixent
Dupixent是使用Regeneron的專有VelociMmune技術發明的,是一種完全人源的單克隆抗體,可抑制白介素-4(IL-4)和白介素-13(IL-13)途徑的信號傳導,不是免疫抑制劑。在 3 期試驗中,Dupixent 開發計劃顯示出顯著的臨床益處和 2 型炎症的減少,這表明 IL-4 和 IL-13 是 2 型炎症的關鍵和核心驅動因素,二型炎症在多種相關且往往是併發疾病中起着重要作用。
Dupixent has received regulatory approvals in more than 60 countries in one or more indications including certain patients with atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis (CRSwNP), eosinophilic esophagitis (EoE), prurigo nodularis, chronic spontaneous urticaria (CSU), and COPD in different age populations. More than 950,000 patients are being treated with Dupixent globally.
Dupixent在一項或多項適應症中獲得了60多個國家的監管批准,其中包括不同年齡人群中的某些特應性皮炎、哮喘、慢性鼻竇炎伴鼻息肉(crsWnP)、嗜酸性食管炎(EoE)、結節性瘙癢、慢性自發性蕁麻疹(CSU)和慢性阻塞性肺病患者。全球有超過95萬名患者正在接受Dupixent的治療。
Dupilumab Development Program
Dupilumab is being jointly developed by Regeneron and Sanofi under a global collaboration agreement. To date, dupilumab has been studied across more than 60 clinical trials involving more than 10,000 patients with various chronic diseases driven in part by type 2 inflammation.
Dupilumab 開發計劃
Dupilumab由Regeneron和賽諾菲根據一項全球合作協議共同開發。迄今爲止,dupilumab已在60多項臨床試驗中進行了研究,涉及10,000多名患有各種慢性病的患者,部分原因是2型炎症。
In addition to the currently approved indications, Regeneron and Sanofi are studying dupilumab in a broad range of diseases driven by type 2 inflammation or other allergic processes in Phase 3 trials, including chronic pruritus of unknown origin and bullous pemphigoid. These potential uses of dupilumab are currently under clinical investigation, and the safety and efficacy in these conditions have not been fully evaluated by any regulatory authority.
除了目前批准的適應症外,Regeneron和賽諾菲還在3期試驗中研究dupilumab用於由2型炎症或其他過敏過程驅動的各種疾病,包括來歷不明的慢性瘙癢症和大皰性類天皰瘡。dupilumab的這些潛在用途目前正在臨床研究中,任何監管機構尚未對這些疾病的安全性和有效性進行全面評估。
About Itepekimab
Itepekimab, which was invented using Regeneron's proprietary VelocImmune technology, is a fully human monoclonal antibody that binds to and inhibits the signaling of interleukin-33 (IL-33), an initiator and amplifier of airway inflammation.
關於 Itepekimab
Itepekimab是使用Regeneron的專有VelociMmune技術發明的,是一種完全人源的單克隆抗體,可結合並抑制氣道炎症的引發劑和放大器白介素-33(IL-33)的信號傳導。
Itepekimab is currently under clinical investigation in two COPD Phase 3 trials and its safety and efficacy have not been evaluated by any regulatory authority.
Itepekimab目前正在兩項慢性阻塞性肺病3期試驗中進行臨床研究,其安全性和有效性尚未經過任何監管機構的評估。
About Regeneron's VelocImmune Technology
Regeneron's VelocImmune technology utilizes a proprietary genetically engineered mouse platform endowed with a genetically humanized immune system to produce optimized fully human antibodies. When Regeneron's co-Founder, President and Chief Scientific Officer George D. Yancopoulos was a graduate student with his mentor Frederick W. Alt in 1985, they were the first to envision making such a genetically humanized mouse, and Regeneron has spent decades inventing and developing VelocImmune and related VelociSuite technologies. Dr. Yancopoulos and his team have used VelocImmune technology to create a substantial proportion of all original, FDA-approved or authorized fully human monoclonal antibodies. This includes REGEN-COV (casirivimab and imdevimab), Dupixent, Libtayo (cemiplimab-rwlc), Praluent (alirocumab), Kevzara (sarilumab), Evkeeza (evinacumab-dgnb), Inmazeb (atoltivimab, maftivimab and odesivimab-ebgn) and Veopoz (pozelimab-bbfg).
關於 Regeneron 的 VelociMmune 技術
Regeneron 的 VelociMmune 技術利用具有基因人源化免疫系統的專有基因工程小鼠平台來生產經過優化的全人類抗體。1985年,當Regeneron的聯合創始人、總裁兼首席科學官喬治·揚科普洛斯與他的導師弗雷德裏克·沃爾特一起讀研究生時,他們是第一個設想製造這種基因人源化小鼠的人,Regeneron花了數十年的時間發明和開發VelociSuite和相關的VelociSuite技術。揚科普洛斯博士及其團隊使用VelociMmune技術製造了所有原創、經美國食品藥品管理局批准或授權的完全人源單克隆抗體的很大一部分。這包括 REGEN-COV(卡西里維單抗和 imdevimab)、Dupixent、Libtayo(cemiplimab-rwlc)、Praluent(alirocumab)、Kevzara(sarilumab)、Evkeeza(evinacumab-dgnb)、Inmazeb(阿托爾替維單抗、馬替維單抗和 odesivimab-ebgn)和 Veopoz(pozelimab-bbfg)。
U.S. INDICATIONS
DUPIXENT is a prescription medicine used:
美國的適應症
dupiXent 是一種處方藥,用於:
to treat adults and children 6 months of age and older with moderate-to-severe eczema (atopic dermatitis or AD) that is not well controlled with prescription therapies used on the skin (topical), or who cannot use topical therapies. DUPIXENT can be used with or without topical corticosteroids. It is not known if DUPIXENT is safe and effective in children with atopic dermatitis under 6 months of age.
with other asthma medicines for the maintenance treatment of moderate-to-severe eosinophilic or oral steroid dependent asthma in adults and children 6 years of age and older whose asthma is not controlled with their current asthma medicines. DUPIXENT helps prevent severe asthma attacks (exacerbations) and can improve your breathing. DUPIXENT may also help reduce the amount of oral corticosteroids you need while preventing severe asthma attacks and improving your breathing. DUPIXENT is not used to treat sudden breathing problems. It is not known if DUPIXENT is safe and effective in children with asthma under 6 years of age.
with other medicines for the maintenance treatment of chronic rhinosinusitis with nasal polyposis (CRSwNP) in adults whose disease is not controlled. It is not known if DUPIXENT is safe and effective in children with chronic rhinosinusitis with nasal polyposis under 18 years of age.
to treat adults and children 1 year of age and older with eosinophilic esophagitis (EoE), who weigh at least 33 pounds (15 kg). It is not known if DUPIXENT is safe and effective in children with eosinophilic esophagitis under 1 year of age, or who weigh less than 33 pounds (15 kg).
to treat adults with prurigo nodularis (PN). It is not known if DUPIXENT is safe and effective in children with prurigo nodularis under 18 years of age.
用於治療患有中度至重度溼疹(特應性皮炎或 AD)的成人和6個月及以上的兒童,這種溼疹無法通過皮膚處方療法(局部用藥)得到很好的控制,或者不能使用局部療法。dupiXent 可以與局部皮質類固醇一起使用,也可以不與局部使用皮質類固醇。尚不清楚dupiXent對6個月以下患有特應性皮炎的兒童是否安全有效。
與其他哮喘藥物合用,用於維持治療中度至重度嗜酸性或口服類固醇依賴性哮喘的成人和6歲及以上兒童的中度至重度嗜酸性或口服類固醇依賴性哮喘。dupiXent 有助於預防嚴重的哮喘發作(惡化),並可以改善您的呼吸。dupiXent 還可以幫助減少所需的口服皮質類固醇的用量,同時防止嚴重的哮喘發作和改善呼吸。dupiXent 不用於治療突然的呼吸問題。目前尚不清楚dupiXent對6歲以下的哮喘兒童是否安全有效。
與其他藥物一起用於維持治療疾病未得到控制的成人慢性鼻竇炎伴鼻息肉(crsWNP)。尚不清楚dupiXent對18歲以下患有慢性鼻竇炎伴鼻息肉的兒童是否安全有效。
用於治療成人和1歲及以上體重至少爲33磅(15千克)的嗜酸性食管炎(EoE)的兒童。尚不清楚dupiXent對1歲以下的嗜酸性食管炎兒童或體重小於33磅(15千克)的兒童是否安全有效。
用於治療結節性瘙癢(PN)的成年人。尚不清楚dupiXent對18歲以下結節性瘙癢症兒童是否安全有效。
IMPORTANT SAFETY INFORMATION
重要的安全信息
Do not use if you are allergic to dupilumab or to any of the ingredients in DUPIXENT.
如果您對 dupilumab 或 dupiXent 中的任何成分過敏,請勿使用。
Before using DUPIXENT, tell your healthcare provider about all your medical conditions, including if you:
在使用 dupiXent 之前,請告知您的醫療保健提供者您的所有醫療狀況,包括您是否:
have eye problems.
have a parasitic (helminth) infection.
are scheduled to receive any vaccinations. You should not receive a "live vaccine" right before and during treatment with DUPIXENT.
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are pregnant or plan to become pregnant. It is not known whether DUPIXENT will harm your unborn baby.
A pregnancy registry for women who take DUPIXENT during pregnancy collects information about the health of you and your baby. To enroll or get more information call 1-877-311-8972 or go to .
are breastfeeding or plan to breastfeed. It is not known whether DUPIXENT passes into your breast milk.
有眼部問題。
患有寄生蟲(蠕蟲)感染。
計劃接種任何疫苗。在使用dupiXent治療之前和治療期間,您不應接種 「活疫苗」。
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已懷孕或計劃懷孕。目前尚不清楚 dupiXent 是否會傷害你未出生的嬰兒。
懷孕期間服用 dupiXent 的女性的妊娠登記處收集有關您和寶寶健康狀況的信息。要註冊或獲取更多信息,請致電 1-877-311-8972 或前往。
正在母乳餵養或計劃母乳餵養。目前尚不清楚 dupiXent 是否會進入你的母乳。
Tell your healthcare provider about all the medicines you take, including prescription and over-the- counter medicines, vitamins, and herbal supplements.
告訴您的醫療保健提供者您服用的所有藥物,包括處方藥和非處方藥、維生素和草藥補充劑。
Especially tell your healthcare provider if you are taking oral, topical, or inhaled corticosteroid medicines; have asthma and use an asthma medicine; or have atopic dermatitis, chronic rhinosinusitis with nasal polyposis, eosinophilic esophagitis, or prurigo nodularis and also have asthma. Do not change or stop your corticosteroid medicine or other asthma medicine without talking to your healthcare provider. This may cause other symptoms that were controlled by the corticosteroid medicine or other asthma medicine to come back.
如果您正在服用口服、局部或吸入性皮質類固醇藥物;患有哮喘並正在使用哮喘藥物;或患有特應性皮炎、伴有鼻息肉的慢性鼻竇炎、嗜酸性食道炎或結節性瘙癢症以及哮喘,請特別告知您的醫療服務提供者。在未與您的醫療服務提供者交談之前,請勿更換或停用皮質類固醇藥物或其他哮喘藥物。這可能會導致皮質類固醇藥物或其他哮喘藥物控制的其他症狀復發。
DUPIXENT can cause serious side effects, including:
dupiXent 可能會導致嚴重的副作用,包括:
Allergic reactions. DUPIXENT can cause allergic reactions that can sometimes be severe. Stop using DUPIXENT and tell your healthcare provider or get emergency help right away if you get any of the following signs or symptoms: breathing problems or wheezing, swelling of the face, lips, mouth, tongue or throat, fainting, dizziness, feeling lightheaded, fast pulse, fever, hives, joint pain, general ill feeling, itching, skin rash, swollen lymph nodes, nausea or vomiting, or cramps in your stomach-area.
Eye problems. Tell your healthcare provider if you have any new or worsening eye problems, including eye pain or changes in vision, such as blurred vision. Your healthcare provider may send you to an ophthalmologist for an exam if needed.
Inflammation of your blood vessels. Rarely, this can happen in people with asthma who receive DUPIXENT. This may happen in people who also take a steroid medicine by mouth that is being stopped or the dose is being lowered. It is not known whether this is caused by DUPIXENT. Tell your healthcare provider right away if you have: rash, chest pain, worsening shortness of breath, a feeling of pins and needles or numbness of your arms or legs, or persistent fever.
Joint aches and pain. Some people who use DUPIXENT have had trouble walking or moving due to their joint symptoms, and in some cases needed to be hospitalized. Tell your healthcare provider about any new or worsening joint symptoms. Your healthcare provider may stop DUPIXENT if you develop joint symptoms.
過敏反應。dupiXent 可能引起過敏反應,有時可能很嚴重。如果您出現以下任何體徵或症狀,請停止使用DupiXent並立即告知您的醫療服務提供者或尋求緊急幫助:呼吸問題或喘息,面部、嘴脣、嘴巴、舌頭或喉嚨腫脹,昏厥,頭暈,感覺頭暈,脈搏快,發燒,麻疹,全身不適,瘙癢,皮疹,淋巴結腫大,噁心或嘔吐,或抽筋胃部區域。
眼部問題。如果您有任何新的或惡化的眼部問題,包括眼痛或視力變化,例如視力模糊,請告知您的醫療服務提供者。如果需要,您的醫療保健提供者可能會派您去看眼科醫生進行檢查。
血管發炎。這種情況很少發生在接受dupiXent治療的哮喘患者身上。這可能發生在同時口服類固醇藥物但已停止服用或正在降低劑量的人身上。目前尚不清楚這是否是由dupiXent造成的。如果您出現以下症狀,請立即告知您的醫療服務提供者:皮疹、胸痛、呼吸急促惡化、針刺感、手臂或腿部麻木感或持續發燒。
關節疼痛。一些使用dupiXent的人由於關節症狀而難以行走或移動,在某些情況下需要住院。將任何新的或惡化的關節症狀告知您的醫療服務提供者。如果您出現關節症狀,您的醫療保健提供者可能會停用 dupiXent。
The most common side effects include:
最常見的副作用包括:
Eczema: injection site reactions, eye and eyelid inflammation, including redness, swelling, and itching, sometimes with blurred vision, dry eye, cold sores in your mouth or on your lips, and high count of a certain white blood cell (eosinophilia).
Asthma: injection site reactions, high count of a certain white blood cell (eosinophilia), pain in the throat (oropharyngeal pain), and parasitic (helminth) infections.
Chronic Rhinosinusitis with Nasal Polyposis: injection site reactions, eye and eyelid inflammation, including redness, swelling, and itching, sometimes with blurred vision, high count of a certain white blood cell (eosinophilia), gastritis, joint pain (arthralgia), trouble sleeping (insomnia), and toothache.
Eosinophilic Esophagitis: injection site reactions, upper respiratory tract infections, cold sores in your mouth or on your lips, and joint pain (arthralgia).
Prurigo Nodularis: eye and eyelid inflammation, including redness, swelling, and itching, sometimes with blurred vision, herpes virus infections, common cold symptoms (nasopharyngitis), dizziness, muscle pain, and diarrhea.
溼疹:注射部位反應、眼睛和眼瞼發炎,包括髮紅、腫脹和瘙癢,有時伴有視力模糊、眼睛乾澀、口腔或嘴脣出現脣皰疹以及特定白細胞(嗜酸性粒細胞增多)的高計數。
哮喘:注射部位反應、特定白細胞計數過高(嗜酸性粒細胞增多)、喉嚨痛(口咽痛)和寄生蟲(蠕蟲)感染。
慢性鼻竇炎伴鼻息肉:注射部位反應、眼睛和眼皮發炎,包括髮紅、腫脹和瘙癢,有時伴有視力模糊、特定白細胞計數過高(嗜酸性粒細胞增多)、胃炎、關節痛(關節痛)、睡眠困難(失眠)和牙痛。
嗜酸性食管炎:注射部位反應、上呼吸道感染、口腔或脣部脣皰疹以及關節痛(關節痛)。
結節性瘙癢:眼睛和眼瞼發炎,包括髮紅、腫脹和瘙癢,有時伴有視力模糊、皰疹病毒感染、普通感冒症狀(鼻咽炎)、頭暈、肌肉疼痛和腹瀉。
Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
如果您有任何困擾您或沒有消失的副作用,請告訴您的醫療保健提供者。
These are not all the possible side effects of DUPIXENT. Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit , or call 1-800-FDA-1088.
這些並不是dupiXent可能產生的全部副作用。致電您的醫生,獲取有關副作用的醫療建議。我們鼓勵您向 FDA 報告處方藥的負面副作用。訪問或致電 1-800-FDA-1088。
Use DUPIXENT exactly as prescribed by your healthcare provider. It's an injection given under the skin (subcutaneous injection). Your healthcare provider will decide if you or your caregiver can inject DUPIXENT. Do not try to prepare and inject DUPIXENT until you or your caregiver have been trained by your healthcare provider. In children 12 years of age and older, it's recommended DUPIXENT be administered by or under supervision of an adult. In children 6 months to less than 12 years of age, DUPIXENT should be given by a caregiver.
完全按照您的醫療保健提供者的處方使用 dupiXent。這是一種皮下注射(皮下注射)。您的醫療保健提供者將決定您或您的護理人員是否可以注射 dupiXent。在您或您的護理人員接受過醫療保健提供者的培訓之前,不要嘗試準備和注射 dupiXent。對於 12 歲及以上的兒童,建議由成人或在成人監督下使用 dupiXent。對於6個月至12歲以下的兒童,dupiXent應由看護人提供。
Please see accompanying full Prescribing Information including Patient Information.
請查看隨附的完整處方信息,包括患者信息。
About Regeneron
Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents, develops and commercializes life-transforming medicines for people with serious diseases. Founded and led by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to numerous approved treatments and product candidates in development, most of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurological diseases, hematologic conditions, infectious diseases, and rare diseases.
關於 Regeneron
Regeneron(納斯達克股票代碼:REGN)是一家領先的生物技術公司,爲嚴重疾病患者發明、開發和商業化改變生活的藥物。我們由醫師兼科學家創立和領導,具有反覆持續地將科學轉化爲醫學的獨特能力,促成了許多獲得批准的療法和候選產品正在開發中,其中大多數是在我們的實驗室中本土研發的。我們的藥物和產品線旨在幫助患有眼部疾病、過敏和炎性疾病、癌症、心血管和代謝疾病、神經系統疾病、血液系統疾病、傳染病和罕見疾病的患者。
Regeneron pushes the boundaries of scientific discovery and accelerates drug development using our proprietary technologies, such as VelociSuite, which produces optimized fully human antibodies and new classes of bispecific antibodies. We are shaping the next frontier of medicine with data-powered insights from the Regeneron Genetics Center and pioneering genetic medicine platforms, enabling us to identify innovative targets and complementary approaches to potentially treat or cure diseases.
Regeneron 利用我們的專有技術(例如 VelociSuite)突破科學發現的界限並加速藥物開發,該技術可產生經過優化的全人體抗體和新的雙特異性抗體。我們正在利用Regeneron Genetics Center和開創性基因醫學平台的數據驅動見解塑造下一個醫學前沿,使我們能夠確定可能治療或治癒疾病的創新靶標和補充方法。
For more information, please visit or follow Regeneron on LinkedIn, Instagram, Facebook or X.
欲了解更多信息,請在 LinkedIn、Instagram、Facebook 或 X 上訪問或關注 Regeneron
Regeneron Forward-Looking Statements and Use of Digital Media
This press release includes forward-looking statements that involve risks and uncertainties relating to future events and the future performance of Regeneron Pharmaceuticals, Inc. ("Regeneron" or the "Company"), and actual events or results may differ materially from these forward-looking statements. Words such as "anticipate," "expect," "intend," "plan," "believe," "seek," "estimate," variations of such words, and similar expressions are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. These statements concern, and these risks and uncertainties include, among others, the nature, timing, and possible success and therapeutic applications of products marketed or otherwise commercialized by Regeneron and/or its collaborators or licensees (collectively, "Regeneron's Products") and product candidates being developed by Regeneron and/or its collaborators or licensees (collectively, "Regeneron's Product Candidates") and research and clinical programs now underway or planned, including without limitation Dupixent (dupilumab) and itepekimab; uncertainty of the utilization, market acceptance, and commercial success of Regeneron's Products and Regeneron's Product Candidates and the impact of studies (whether conducted by Regeneron or others and whether mandated or voluntary), including the studies discussed or referenced in this press release, on any of the foregoing or any potential regulatory approval of Regeneron's Products (such as Dupixent) and Regeneron's Product Candidates (such as itepekimab); the likelihood, timing, and scope of possible regulatory approval and commercial launch of Regeneron's Product Candidates and new indications for Regeneron's Products, including itepekimab for the treatment of chronic obstructive pulmonary disease as well as Dupixent for the treatment of chronic pruritus of unknown origin, bullous pemphigoid, and other potential indications; the ability of Regeneron's collaborators, licensees, suppliers, or other third parties (as applicable) to perform manufacturing, filling, finishing, packaging, labeling, distribution, and other steps related to Regeneron's Products and Regeneron's Product Candidates; the ability of Regeneron to manage supply chains for multiple products and product candidates; safety issues resulting from the administration of Regeneron's Products (such as Dupixent) and Regeneron's Product Candidates (such as itepekimab) in patients, including serious complications or side effects in connection with the use of Regeneron's Products and Regeneron's Product Candidates in clinical trials; determinations by regulatory and administrative governmental authorities which may delay or restrict Regeneron's ability to continue to develop or commercialize Regeneron's Products and Regeneron's Product Candidates; ongoing regulatory obligations and oversight impacting Regeneron's Products, research and clinical programs, and business, including those relating to patient privacy; the availability and extent of reimbursement of Regeneron's Products from third-party payers, including private payer healthcare and insurance programs, health maintenance organizations, pharmacy benefit management companies, and government programs such as Medicare and Medicaid; coverage and reimbursement determinations by such payers and new policies and procedures adopted by such payers; competing drugs and product candidates that may be superior to, or more cost effective than, Regeneron's Products and Regeneron's Product Candidates; the extent to which the results from the research and development programs conducted by Regeneron and/or its collaborators or licensees may be replicated in other studies and/or lead to advancement of product candidates to clinical trials, therapeutic applications, or regulatory approval; unanticipated expenses; the costs of developing, producing, and selling products; the ability of Regeneron to meet any of its financial projections or guidance and changes to the assumptions underlying those projections or guidance; the potential for any license, collaboration, or supply agreement, including Regeneron's agreements with Sanofi and Bayer (or their respective affiliated companies, as applicable) to be cancelled or terminated; the impact of public health outbreaks, epidemics, or pandemics (such as the COVID-19 pandemic) on Regeneron's business; and risks associated with intellectual property of other parties and pending or future litigation relating thereto (including without limitation the patent litigation and other related proceedings relating to EYLEA (aflibercept) Injection), other litigation and other proceedings and government investigations relating to the Company and/or its operations (including the pending civil proceedings initiated or joined by the U.S. Department of Justice and the U.S. Attorney's Office for the District of Massachusetts), the ultimate outcome of any such proceedings and investigations, and the impact any of the foregoing may have on Regeneron's business, prospects, operating results, and financial condition. A more complete description of these and other material risks can be found in Regeneron's filings with the U.S. Securities and Exchange Commission, including its Form 10-K for the year ended December 31, 2023 and its Form 10-Q for the quarterly period ended June 30, 2024. Any forward-looking statements are made based on management's current beliefs and judgment, and the reader is cautioned not to rely on any forward-looking statements made by Regeneron. Regeneron does not undertake any obligation to update (publicly or otherwise) any forward-looking statement, including without limitation any financial projection or guidance, whether as a result of new information, future events, or otherwise.
Regeneron 前瞻性陳述和數字媒體的使用
本新聞稿包括前瞻性陳述,涉及與Regeneron Pharmicals, Inc.(「Regeneron」 或 「公司」)的未來事件和未來業績相關的風險和不確定性,實際事件或結果可能與這些前瞻性陳述存在重大差異。諸如 「預期」、「期望」、「打算」、「計劃」、「相信」、「尋求」、「估計」 之類的詞語以及此類詞語的變體以及類似的表述旨在識別此類前瞻性陳述,儘管並非所有前瞻性陳述都包含這些識別詞。這些聲明涉及到,這些風險和不確定性包括由Regeneron和/或其合作者或被許可人銷售或以其他方式商業化的產品(統稱爲 「Regeneron的產品」)、Regeneron和/或其合作者或被許可人正在開發的候選產品(統稱爲 「Regeneron的候選產品」)以及正在進行或計劃中的研究和臨床項目,包括沒有的研究和臨床項目的性質、時機、可能的成功和治療應用侷限性 Dupixent (dupilumab) 和 itepekimab;不確定性Regeneron產品和Regeneron候選產品的使用情況、市場接受度和商業成功程度,以及研究(無論是由Regeneron還是其他公司進行的,無論是強制性還是自願性的),包括本新聞稿中討論或引用的研究,對Regeneron的產品(例如Dupixent)和Regeneron候選產品(例如itepekimab)的任何上述或任何潛在監管批准的影響;Regeneron 產品可能獲得監管批准和商業上市的可能性、時間和範圍Regeneron產品的候選藥物和新適應症,包括用於治療慢性阻塞性肺病的itepekimab以及用於治療不明來源的慢性瘙癢、大皰性類天皰瘡和其他潛在適應症的Dupixent;Regeneron的合作伙伴、被許可人、供應商或其他第三方(如適用)進行製造、灌裝、精加工、包裝、貼標、分銷的能力,以及與Regeneron的產品和Regeneron的候選產品相關的其他步驟;Regeneron的管理能力多種產品和候選產品的供應鏈;因在患者中管理Regeneron的產品(例如Dupixent)和Regeneron的候選產品(例如itepekimab)而導致的安全問題,包括與在臨床試驗中使用Regeneron產品和Regeneron的候選產品相關的嚴重併發症或副作用;政府監管和行政機構做出的可能延遲或限制Regeneron繼續使用Regeneron的能力的決定開發或商業化 Regeneron 的產品和 Regeneron的候選產品;影響Regeneron產品、研究和臨床計劃及業務的持續監管義務和監督,包括與患者隱私相關的業務;第三方付款人向Regeneron產品報銷的可用性和範圍,包括私人付款人醫療保健和保險計劃、健康維護組織、藥房福利管理公司以及醫療保險和醫療補助等政府計劃;此類付款人的承保範圍和報銷決定以及採用的新政策和程序由此類付款人提供;可能優於 Regeneron 產品和 Regeneron 候選產品或更具成本效益的競爭藥物和候選產品;Regeneron 和/或其合作者或被許可人開展的研發計劃的結果在多大程度上可在其他研究中複製和/或導致候選產品進入臨床試驗、治療應用或監管機構批准;意外開支;開發、生產的成本和銷售產品;Regeneron 的滿足能力其任何財務預測或指導以及對這些預測或指導所依據假設的變更;任何許可、合作或供應協議,包括Regeneron與賽諾菲和拜耳(或其各自的關聯公司,視情況而定)的協議被取消或終止的可能性;公共衛生疫情、流行病或流行病(例如 COVID-19 疫情)對Regeneron業務的影響;以及與其他知識產權相關的風險當事方以及與之相關的未決或未來訴訟 (包括但不限於與EYLEA(aflibercept)注入)相關的專利訴訟和其他相關訴訟、與公司和/或其業務有關的其他訴訟和其他程序以及政府調查(包括美國司法部和美國馬薩諸塞特區檢察官辦公室發起或加入的未決民事訴訟)、任何此類訴訟和調查的最終結果以及上述任何內容可能對Regeneron業務產生的影響,前景、經營業績和財務狀況。對這些風險和其他重大風險的更完整描述可以在Regeneron向美國證券交易委員會提交的文件中找到,包括截至2023年12月31日的年度的10-k表和截至2024年6月30日的季度期的10-Q表格。任何前瞻性陳述都是根據管理層當前的信念和判斷做出的,提醒讀者不要依賴Regeneron的任何前瞻性陳述。Regeneron不承擔任何義務更新(公開或以其他方式)任何前瞻性陳述,包括但不限於任何財務預測或指導,無論是由於新信息、未來事件還是其他原因。
Regeneron uses its media and investor relations website and social media outlets to publish important information about the Company, including information that may be deemed material to investors. Financial and other information about Regeneron is routinely posted and is accessible on Regeneron's media and investor relations website () and its LinkedIn page ().
Regeneron使用其媒體和投資者關係網站以及社交媒體發佈有關公司的重要信息,包括可能被視爲對投資者至關重要的信息。有關Regeneron的財務和其他信息定期發佈,可在Regeneron的媒體和投資者關係網站()及其LinkedIn頁面()上訪問。
Regeneron Contacts: |
Investor Relations |
Regeneron 聯繫方式: |
投資者關係 |
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Source: Regeneron Pharmaceuticals, Inc.
來源:Regeneron Pharmicals, Inc.