Unresolved questions about the clinical efficacy of a hypotension drug that received accelerated approval 23 years ago highlight the challenges the US Food and Drug Administration and its external advisors will face in weighing whether AMAG Pharmaceuticals Inc.'s preterm birth drug Makena should remain on the market despite failure to confirm clinical benefit.
On 29 October, the FDA will convene its Bone, Reproductive and Urologic Drugs Advisory Committee to consider the continued availability of Makena (hydroxyprogesterone caproate injection, also known as 17P), an accelerated approval drug for which the required confirmatory trial failed to demonstrate a statistically significant treatment difference on two co-primary endpoints