FDA Requests Withdrawal Of Makena And Generics
Hydroxyprogesterone Withdrawal Request Goes Beyond Failed Confirmatory Trial
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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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.
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.
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.