FDA ac­cepts Bris­tol My­er­s' pitch for for­mer MyoKar­dia drug; Clo­vis' Rubra­ca aces ad­vanced ovar­i­an can­cer study

The pro­gram at the cen­ter­piece of Bris­tol My­ers Squibb’s buy­out of MyoKar­dia just got one step clos­er to gain­ing po­ten­tial FDA ap­proval.

BMS an­nounced Fri­day that the agency has ac­cept­ed its NDA pitch, sched­ul­ing a Jan. 28, 2022 PDU­FA date for the ex­per­i­men­tal drug mava­camten. The com­pa­ny is shoot­ing for an ini­tial in­di­ca­tion of symp­to­matic ob­struc­tive hy­per­trophic car­diomy­opa­thy, or oHCM.

In the dis­ease, a mu­ta­tion in pro­teins forces the heart to ex­ert more ef­fort and squeeze more, block­ing the out­flow of blood and thick­en­ing mus­cle. Mava­camten is an oral al­losteric mod­u­la­tor of car­diac myosin, in­tend­ed to re­duce con­trac­tion by the heart mus­cle.

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