FDA panel to meet late October on AMAG’s Makena for preterm births

The FDA will hold an advisory committee meeting on Tuesday, October 29, to review and discuss the results from a failed Phase 3 clinical trial, PROLONG, evaluating AMAG Pharmaceuticals’ (AMAG -1.9%) Makena (hydroxyprogesterone caproate injection) for preventing preterm births in women with histories of prior spontaneous singleton preterm deliveries.

Shares sold off in March when the company announced that Makena failed to separate from placebo as measured by the rate of preterm delivery.

The FDA approved it in February 2011 to reduce the risk of preterm birth in at-risk pregnant women.

https://seekingalpha.com/news/3501133-fda-advisory-committee-meet-late-october-amags-makena-preterm-births