Sponsor’s assertion that recruitment of high-risk, US patients was negatively impacted by the preterm birth drug’s availability under accelerated approval led some advisory committee members to opine that Makena came to market too soon; the experience could make the FDA more cautious about granting accelerated approval unless confirmatory studies are at an advanced stage.
The failed confirmatory trial for AMAG Pharmaceuticals Inc.'s Makena leaves the US Food and Drug Administration with a no-win decision on whether to withdraw the only approved drug for preventing recurrent preterm birth.
However, the experience with the PROLONG trial could have an impact beyond just Makena, potentially making the agency more cautious...