A group of advisers to the Food and Drug Administration voted in favor of Alnylam Pharmaceuticals’ treatment for a debilitating heart disease Wednesday, but only after a day-long debate challenging whether the drug’s modest observed effects were actually meaningful for patients.
The group of independent experts voted 9-3 that the benefits of Alnylam’s drug, called patisiran, outweighed its risks for patients with ATTR-CM, a progressive disease that leads to fatal heart failure if left untreated. The FDA, which is not required to follow the advice of advisers, is expected to make a final decision on patisiran by Oct. 8.
advertisement
“It’s like a light wind blowing in favor of patisiran over placebo,” said David Cella, a neurologist at the Northwestern University Feinberg School of Medicine who voted in favor of patisiran. David Moliterno, a cardiologist at the University of Kentucky, added that “the good news in this story is that while there may be a small benefit, it doesn’t look like there’s a signal for harm.”
Get unlimited access to award-winning journalism and exclusive events.
Subscribe Log In
Previous article：
Amylyx's ALS drug launch starts strong. It could be trouble for FDA
Next article： Virginia high school admissions case could be legal follow
Next article： Virginia high school admissions case could be legal follow
