Top CDER lead­ers rake Co­vis over the coals on its failed con­fir­ma­to­ry tri­al, neg­a­tive da­ta

The FDA put all of its high­est-rank­ing CDER of­fi­cials on dis­play Mon­day in the first day of a two-and-a-half-day hear­ing on whether to pull Co­vis Phar­ma’s pre-term birth drug Mak­e­na (hy­drox­yprog­es­terone caproate) and its gener­ic ver­sions from the mar­ket.

Af­ter win­ning an ac­cel­er­at­ed ap­proval in 2011, Mak­e­na failed to beat place­bo on neona­tal mor­bid­i­ty and mor­tal­i­ty from com­pli­ca­tions of preterm birth in a con­fir­ma­to­ry tri­al end­ing in 2018, and a pri­or ad­comm in 2019 vot­ed to pull the drug as Co­vis has con­tin­ued to fight back.

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