AMAG Pharma up 15% ahead of FDA panel for Makena

AMAG Pharmaceuticals (AMAG +14.5%) is up in early trade after the FDA posted the meeting materials for next Tuesday’s meeting of the Bone, Reproductive and Urologic Drugs Advisory Committee to review and discuss its supplemental marketing application seeking full approval of Makena (hydroxyprogesterone caproate injection) for reducing the risk of preterm birth in women with histories of singleton spontaneous preterm birth.

The agency granted accelerated approval in February 2011 based on a surrogate endpoint with the proviso that the company conduct an additional clinical trial to confirm efficacy. In this case, the postapproval trial failed to sufficiently separate from placebo as measured by the reduction in the risk of recurrent preterm birth or improving neonatal morbidity and mortality so the marketing authorization may be withdrawn.

Meeting materials 

https://seekingalpha.com/news/3509728-amag-pharma-15-percent-ahead-ad-com-makena