FDA to weigh how broadly to expand label for Alnylam’s Onpattro
FDA panel votes 9-3 that the benefits of Onpattro to treat ATTR cardiomyopathy outweigh risks
An FDA panel voted 9-3 that the benefits of Onpattro to treat ATTR cardiomyopathy outweighed its risks, although if the agency follows the advice of several of its panelists the drug may be approved for a narrower label than the one Alnylam is seeking.
On Wednesday, FDA’s Cardiovascular and Renal Drugs Advisory Committee voted on whether the benefits of Onpattro patisiran from Alnylam Pharmaceuticals Inc. (NASDAQ:ALNY) outweighed its risks to treat the form of TTR amyloidosis that manifests as cardiomyopathy (ATTR-CM). The drug was approved for polyneuropathy associated with the disease’s hereditary form (hATTR-PN) in 2018, and a broader approval in ATTR could expand the drug’s label to a population that is much larger. Phase III data from Alnylam’s APOLLO-B trial in the indication propelled the company’s shares up 49% when it read out in August 2022 for a gain of more than $8 billion in market cap. ...