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FDA Requests Withdrawal Of Makena And Generics

Hydroxyprogesterone Withdrawal Request Goes Beyond Failed Confirmatory Trial

Executive Summary

Preterm birth prevention drug should come off the market to ensure the accelerated approval pathway does not operate as a lower approval standard, agency says; proposed withdrawal comes almost a year after an advisory committee split on the question of whether Makena should stay on the market in light of delayed, and ultimately unsuccessful, confirmatory study.

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US FDA Tried, But Failed, To Take Compounding Issue Off The Table At Makena AdComm

Clinicians and patients would look for 17P wherever they could find it if AMAG’s FDA-approved formulation of the preterm birth drug comes off the market, panelists said; Cowen analysts believe the potential for safety concerns posed by compounded formulations will save Makena from the regulatory chopping block.

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

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.

AMAG’s Makena: Did Accelerated Approval Kill The Confirmatory Trial?

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.

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