FDA experts vote to yank the agency's 2011 OK of controversial preterm birth drug after a trial failure
Should AMAG continue to be allowed to sell their therapy for preventing preterm births even though their long-running confirmatory study flopped — badly?
That was the question an FDA expert panel had to answer on Tuesday as they heard from people and experts on both sides of the thorny issue. And a slight majority cast their votes in favor of urging the agency to yank the accelerated OK, by a vote of 9 to the 7 who thought the drug should be kept on the market — but only with a new study to provide a definitive answer to the clinical benefit, if any, of Makena.
Keep reading Endpoints with a free subscription
Unlock this story instantly and join 98,000+ biopharma pros reading Endpoints daily — and it's free.