FDA Ad Com thumbs down on full Makena approval

The FDA’s Bone, Reproductive and Urologic Drugs Advisory Committee voted 16-0 that AMAG Pharmaceuticals’ (AMAG) confirmatory study, Trial 003, failed to demonstrate Makena’s effectiveness in reducing the risk of preterm births in women with histories of singleton spontaneous preterm birth.

It voted 13-3 that the clinical data (Trials 002 and 003) in the company’s application failed to demonstrate substantial evidence of effectiveness.

Update: Nine committee members voted to pursue withdrawal from the market while seven voted to leave Makena on the market under accelerated approval and require a new confirmatory trial.

https://seekingalpha.com/news/3510979-fda-ad-com-thumbs-full-makena-approval