AstraZeneca's Asthma Drug Gets FDA Approval For Rare Disease Of Blood Vessel Inflammation
AstraZeneca's Asthma Drug Gets FDA Approval For Rare Disease Of Blood Vessel Inflammation
MANDARA was the first head-to-head non-inferiority trial of biologics in patients with EGPA.The FDA approved on Wednesday AstraZeneca Plc's (NASDAQ:AZN) Fasenra (benralizumab) for eosinophilic granulomatosis with polyangiitis (EGPA), a rare, immune-mediated vasculitis (inflammation of the blood vessels) that can result in damage to multiple organs.
美國食品和藥物管理局週三批准了阿斯利康股份有限公司（納斯達克:AZN）的法塞尼拉（苯拉魯單抗）用於嗜酸性肉芽腫性肉芽腫性多臟器炎（EGPA），這是一種罕見的免疫介導的血管炎（血管炎症），可能導致多個器官受損。
The approval was based on data from the MANDARA Phase 3 trial published in The New England Journal of Medicine, which compared the efficacy and safety of Fasenra to the only approved EGPA treatment, GSK Plc's (NYSE:GSK) Nucala (mepolizumab).
批准是基於《新英格蘭醫學雜誌》發表的MANDARA第3期試驗數據，該數據比較了法塞尼拉與唯一獲批的EGPA治療方法，GSK股份有限公司（紐交所:GSK）的努卡拉（米珀利酞）的療效和安全性。
Also Read: AstraZeneca CEO Pascal Soriot Updates On Chinese Compliance Probe And Lung Cancer Drug Trial Results
阿斯利康CEO帕斯卡爾·索里奧特更新了中國合規調查和肺癌藥物試驗結果。
MANDARA was the first head-to-head non-inferiority trial of biologics in patients with EGPA.
MANDARA是關於EGPA患者的首個頭對頭的非劣效試驗。
In the trial, nearly 60% of Fasenra-treated patients achieved remission, comparable to mepolizumab-treated patients.
在試驗中，近60%的法塞尼拉治療患者實現了緩解，與米珀利酞治療患者相當。
Data also showed 41% of Fasenra-treated patients fully tapered off oral corticosteroids (OCS) (vs. 26% in the mepolizumab arm).
數據還顯示，41%的法塞尼拉治療患者完全停用口服皮質類固醇（OCS）（相對於米珀利酞組的26%）。
The safety and tolerability profile for Fasenra in the MANDARA trial was consistent with the known profile of the medicine.
在MANDARA試驗中，法塞尼拉的安全性和耐受性與藥物已知的特性一致。
Approximately half of patients with EGPA have adult-onset severe eosinophilic asthma and often have sinus and nasal symptoms. Fasenra is the second biologic approved to treat this disease.
大約一半的EGPA患者患有成人發病的重度嗜酸性哮喘，通常伴有鼻竇和鼻部症狀。法塞尼拉是第二個獲批用於治療該疾病的生物製品。
Fasenra is currently approved as an add-on maintenance treatment for severe eosinophilic asthma in over 80 countries.
Fasenra目前已在80多個國家批准用作重度嗜酸粒細胞性哮喘的輔助維持治療。
It is also approved in children and adolescents ages six and above in the U.S. and Japan.
它還在美國和日本批准用於6歲及以上的兒童和青少年。
Last month, the FDA approved AstraZeneca's Imfinzi (durvalumab) in combination with chemotherapy for adult patients with resectable early-stage non-small cell lung cancer (NSCLC) and no known epidermal growth factor receptor mutations or anaplastic lymphoma kinase rearrangements.
上個月，FDA批准了AstraZeneca的Imfinzi（durvalumab）與化療聯合治療可切除期早期非小細胞肺癌（NSCLC）成人患者，並且沒有已知的表皮生長因子受體突變或間變性淋巴瘤激酶重排。
AZN Price Action: AstraZeneca stock is down 0.16% at $78.41 at publication Wednesday.
AZN股票價格：AstraZeneca股票在週三發佈時下跌0.16％，爲78.41美元。
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Photo: Shutterstock
Photo: shutterstock
