FDA needs three more months to re­view Roche's SMA drug — giv­ing Bio­gen, No­var­tis some re­lief

The first oral drug for spinal mus­cu­lar at­ro­phy was wide­ly ex­pect­ed to be ap­proved by the end of May af­ter pri­or­i­ty re­view. But its de­vel­op­ers at Roche, PTC Ther­a­peu­tics and the SMA Foun­da­tion will now have to wait for three more months.

The FDA said they need the ex­tra time to re­view a bunch of new da­ta Roche has re­cent­ly sub­mit­ted, in­clud­ing re­sults from a tri­al in­volv­ing old­er pa­tients. The good news is that reg­u­la­tors have iden­ti­fied “no sub­stan­tive re­view is­sues” to date, ac­cord­ing to a PTC state­ment.

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