FDA grants hear­ing to dis­cuss with­draw­al of con­tentious preterm birth drug Mak­e­na

The on­go­ing saga sur­round­ing con­tro­ver­sial preterm birth drug Mak­e­na will con­tin­ue as the FDA ap­proved a hear­ing on whether Co­vis Phar­ma should with­draw the med­i­cine af­ter it failed a con­fir­ma­to­ry study, the drug­mak­er an­nounced Thurs­day.

Reg­u­la­tors out­lined their rea­sons for the hear­ing in a Wednes­day let­ter to Co­vis’ lawyers, say­ing not on­ly did Co­vis fol­low the cor­rect pro­ce­dure to re­quest one, but al­so that their ob­jec­tions are “jus­ti­fied.” The move comes two years af­ter that tri­al failed to es­tab­lish clin­i­cal ben­e­fit, and af­ter an ad­comm rec­om­mend­ed the drug should be with­drawn in a 9-7 vote.

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