Dave Marek, Myovant CEO

Pfiz­er and My­ovant’s en­dometrio­sis pain drug Myfem­bree gets an­oth­er FDA nod

Af­ter months of de­lay in its de­ci­sion, the FDA has giv­en a green light to Pfiz­er and My­ovant’s drug Myfem­bree for pain re­lat­ed en­dometrio­sis, a gy­ne­co­log­i­cal con­di­tion as­so­ci­at­ed with mod­er­ate to se­vere pain, mak­ing it the drug’s sec­ond in­di­ca­tion ap­proval.

The FDA had ear­li­er de­layed its de­ci­sion to re­view ad­di­tion­al da­ta it had re­quest­ed from the com­pa­nies re­gard­ing bone min­er­al den­si­ty. The reg­u­la­tors had “iden­ti­fied de­fi­cien­cies that pre­clude dis­cus­sion of la­bel­ing and/or post-mar­ket­ing re­quire­ments and com­mit­ment at this time,” the com­pa­nies had said.

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