Positive outcome of FDA AdCom on Alnylam's Onpattro
A US Food and Drug Administration advisory panel on Wednesday backed the expanded use of Alnylam Pharmaceuticals' (Nasdaq: ALNY) gene silencing drug to treat a type of heart disease associated with a rare organ-damaging disorder.
Trading in Alnylam’s shares was halted yesterday, but in early trading today the stock was down 8.2% at $194.28.
The FDA’s Cardiovascular and Renal Drugs Advisory Committee (CRDAC) meeting to discuss the supplemental New Drug Application (sNDA) for Onpattro (patisiran), an investigational RNAi therapeutic in development for the treatment of the cardiomyopathy of transthyretin-mediated (ATTR) amyloidosis resulted in a nine to three vote that the benefits of patisiran outweigh its risks for the treatment of the cardiomyopathy of ATTR amyloidosis.
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