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AMAG Open To Another Makena Trial, But Also Appears Ready To Challenge Any Withdrawal Request

 
• By Sue Sutter

CEO William Heiden reaffirms commitment to preterm birth drug and suggests AMAG would seek a hearing under the accelerated approval regulations if the US FDA were to request withdrawal; another placebo-controlled confirmatory trial may be possible in European and South American countries, company says.

4 Four brown pieces of puzzle stand on wooden table isolated on gray or white background. empty copy space for inscription or objects. idea, sign, symbol, concept of connecting - Image
How to design studies that will provide confirmatory evidence of Makena's clinical benefit is a puzzle that AMAG and the FDA will have to solve. • Source: Shutterstock

AMAG Pharmaceuticals Inc. is open to conducting another randomized, controlled trial for Makena (hydroxyprogesterone caproate injection, also known as 17P), but the company also appears ready to challenge any effort by the US Food and Drug Administration to withdraw the preterm birth drug’s accelerated approval in the interim.

During a third quarter earnings call on 1 November, company executives addressed analyst questions about the FDA advisory committee meeting three days earlier, at which nine of 16 panelists recommended the agency pursue withdrawal of Makena’s accelerated approval due to the failure of the PROLONG study to confirm clinical benefit

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