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

Executive Summary

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.

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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.

Makena Withdrawal Dilemma: Advisory Cmte. Split Offers No Clear Direction For US FDA

Nine of 16 advisory committee members favored withdrawal of AMAG’s preterm birth drug because substantial evidence of efficacy is lacking and clinical benefit has not been confirmed; seven panelists favored keeping the drug on the market but requiring a new trial.

AMAG’s Explanation For Makena's Failed Confirmatory Trial Faces Skeptical US FDA

Post hoc analyses show no convincing evidence that PROLONG trial's failure to meet its coprimary efficacy endpoints stemmed from baseline risk differences in subjects compared to an earlier trial, agency says; advisory committee is being asked whether to withdraw accelerated approval or keep the drug on the market, with or without a new confirmatory study.

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