Alnylam Pharmaceuticals (ALNY) said late Thursday that the US Food and Drug Administration has approved the supplemental new drug application for its drug Amvuttra for the treatment of cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloidosis (ATTR-CM) in adults.
The approval of the drug, also known as vutrisiran, is meant to reduce cardiovascular mortality, cardiovascular hospitalizations, and urgent heart failure visits, the company said.
ATTR-CM is a rapidly progressive and ultimately heart disease without a cure.
The approval is based on a phase 3 clinical trial in which Amvuttra showed statistically significant improvement compared with a placebo in all of its 10 pre-specified primary and secondary endpoints, reducing mortality by 36% over 42 months, the company said.
免責聲明：投資有風險，本文並非投資建議，以上內容不應被視為任何金融產品的購買或出售要約、建議或邀請，作者或其他用戶的任何相關討論、評論或帖子也不應被視為此類內容。本文僅供一般參考，不考慮您的個人投資目標、財務狀況或需求。TTM對信息的準確性和完整性不承擔任何責任或保證，投資者應自行研究並在投資前尋求專業建議。