FDA preps for DMD drug gener­ics as Sarep­ta has yet to fin­ish its con­fir­ma­to­ry tri­al

The FDA typ­i­cal­ly re­leas­es guid­ance to help gener­ic drug man­u­fac­tur­ers de­vel­op new copy­cats of small mol­e­cule drugs, of­ten­times in prepa­ra­tion for a brand name prod­uct’s patents or ex­clu­siv­i­ty to ex­pire.

This week, FDA re­leased such bioe­quiv­a­lence guid­ance for any gener­ic drug­mak­ers look­ing to take on Sarep­ta’s Duchenne mus­cu­lar dy­s­tro­phy (DMD) drug Ex­ondys 51 (eteplirsen), even though the drug’s spon­sor has yet to con­vert the ac­cel­er­at­ed ap­proval to a full ap­proval, show­ing clin­i­cal ben­e­fit.

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