BridgeBio Pharma Presented Initial Outcomes From The ATTRibute-CM Open-label Extension Study Of Acoramidis In ATTR-CM At The AHA Scientific Sessions; Acoramidis Demonstrated The Earliest Known Time To Separation In Cardiovascular Outcomes In The...
BridgeBio Pharma Presented Initial Outcomes From The ATTRibute-CM Open-label Extension Study Of Acoramidis In ATTR-CM At The AHA Scientific Sessions; Acoramidis Demonstrated The Earliest Known Time To Separation In Cardiovascular Outcomes In The...
BridgeBio Pharma Presented Initial Outcomes From The ATTRibute-CM Open-label Extension Study Of Acoramidis In ATTR-CM At The AHA Scientific Sessions; Acoramidis Demonstrated The Earliest Known Time To Separation In Cardiovascular Outcomes In The ATTRibute-CM Study (3 Months), With Statistically Significant Risk Reduction Of 36% On All-Cause Mortality Alone At Month 36 Within The Open Label Extension
BridgeBio Pharma在AHA科學會議上介紹了Attr-CM中阿科拉米迪的Attribute-CM開放標籤擴展研究的初步結果；Acoramidis在Attribute-CM研究中展示了心血管結果的最早已知分離時間（3個月），在開放標籤擴展中，僅第36個月的全因死亡率就降低了36％
- Acoramidis demonstrated the earliest known time to separation in cardiovascular outcomes in the ATTRibute-CM study (3 months), with statistically significant risk reduction of 36% on All-Cause Mortality (ACM) alone at Month 36 within the Open Label Extension
-Acoramidis在Atribute-CM研究中顯示出心血管預後的最早已知分離時間（3個月），在開放標籤延期的第36個月，僅全因死亡率（ACM）的風險就降低了36％，具有統計學意義的顯著降低
- The continued curve separation of the composite endpoint of ACM and recurrent cardiovascular-related hospitalizations (CVH) emphasizes the importance of early intervention resulting in early and sustained clinical benefits, with acoramidis demonstrating 46% (p<0.0001) and 48% (p<0.0001) reductions in the composite endpoint of ACM and recurrent CVH at Months 36 and 42, respectively
-acoramidis的複合終點和心血管相關復發住院（CVH）的持續曲線分離凸顯了早期干預產生早期和持續臨床益處的重要性，阿科拉米德表明，在第36個月和第42個月，acm和複發性心血管相關住院的複合終點分別降低了46％（p
- The preliminary results from this ongoing OLE study were also simultaneously published in Circulation
-這項正在進行的OLE研究的初步結果也同時發表在《Circulation》上
- A New Drug Application for acoramidis for the treatment of ATTR-CM is currently under review with the FDA, with a PDUFA action date of November 29, 2024
-美國食品藥品管理局目前正在審查用於治療Attr-CM的阿科拉米的新藥申請，PDUFA的生效日期爲2024年11月29日
PALO ALTO, Calif., Nov. 18, 2024 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (NASDAQ:BBIO) ("BridgeBio" or the "Company"), a new type of biopharmaceutical company focused on genetic diseases, presented positive initial outcomes from the ATTRibute-CM open-label extension (OLE) study of acoramidis in ATTR-CM at the American Heart Association (AHA) Scientific Sessions. ATTRibute-CM was designed to evaluate the efficacy and safety of acoramidis, an investigational, near-complete, orally-administered, small molecule stabilizer of TTR. The preliminary results from this ongoing OLE study were also simultaneously published in Circulation. The OLE study involves 330 participants who completed the 30-month ATTRibute-CM Phase 3 study.
加利福尼亞州帕洛阿爾託，2024年11月18日（GLOBE NEWSWIRE）——專注於遺傳病的新型生物製藥公司BridgeBio Pharma, Inc.（納斯達克股票代碼：BBIO）（「BridgeBio」 或 「公司」）公佈了美國心臟協會（AHA）Scientific對Atr-CM中阿科拉米德的Atrite-CM開放標籤延期（OLE）研究的積極初步結果會話。Attribute-CM 旨在評估阿科拉米的療效和安全性，阿科拉米是一種正在研究的、近乎完整、口服給藥的 TTR 小分子穩定劑。這項正在進行的OLE研究的初步結果也同時發表在《Circulation》上。OLE研究涉及330名參與者，他們完成了爲期30個月的Attribute-CM第三階段研究。
