据生物制药公司BridgeBio于11月22日宣布,美国食品药品监督管理局(FDA)批准了Attruby (acoramidis),用于治疗患有ATTR-CM的成年人,以减少心血管死亡和心血管相关的住院治疗。新闻稿中指出,Attruby是第一个也是唯一一个药物标签上标明TTR 接近完全稳定(≥90%) 的药物。
BridgeBio Pharma的Attruby提前获批和强有力的标签,加上其有利的定价和预期的广泛使用,表明公司的市场表现前景乐观。该药物在其治疗领域对患者护理和治疗选择的潜在重大影响,现在成为投资者和行业观察者关注的焦点。
Attruby (acoramidis), a near complete TTR stabilizer, has been approved by FDA to reduce cardiovascular death and ...
11/23
11/23,FDA 批准 BridgeBio Pharma $BridgeBio Pharma(BBIO)$ 的 Attruby (acoramidis) 用于降低转甲状腺素蛋白淀粉样心肌病 (ATTR-CM) 患者的心血管死亡和心血管相关住院率,与辉瑞的 tafamidis 展开直接竞争,后者具有相同的作用机制,但批准的适应症更有限。 Attruby 是一种口服 TTR 稳定剂,FDA的批准称该 ...
周一,在公司新药获得提前批准后,分析师对BridgeBio Pharma (NASDAQ:BBIO)保持了乐观展望。派杰证券重申了对该股的增持评级,目标价维持在46.00美元。用于治疗ATTR-CM的acoramidis(Attruby)获得批准的时间早于原定的11月29日处方药用户费用法案(PDUFA)日期。
Among important regulatory news last week, US drugmaker BridgeBio Pharma gained Food and Drug Administration (FDA) approval ...
The US Food and Drug Administration (FDA) has approved BridgeBio Pharma’s Attruby (acoramidis), an oral transthyretin (TTR) ...
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The US Food and Drug Administration (FDA) has approved BridgeBio Pharma’s Attruby (acoramidis) to treat adults with ...
BridgeBio announced the FDA approval of Attruby (acoramidis) for the treatment of patients with ATTR-CM. The label looks clean and it includes all the relevant clinical data. Attruby's approval ...