Sanofi grap­ples with re­jec­tion of po­ten­tial first-in-class or­phan drug, faults third-par­ty man­u­fac­tur­ing

A snap re­view didn’t lead to a quick OK for Sanofi’s su­tim­limab. A day af­ter the FDA’s sup­posed de­ci­sion date on the or­phan drug, the French phar­ma gi­ant said it was hand­ed a re­jec­tion.

The com­plete re­sponse let­ter cites “cer­tain de­fi­cien­cies iden­ti­fied by the agency dur­ing a pre-li­cense in­spec­tion of a third-par­ty fa­cil­i­ty re­spon­si­ble for man­u­fac­tur­ing,” Sanofi wrote. Reg­u­la­tors ap­par­ent­ly didn’t take any is­sue with the clin­i­cal da­ta or safe­ty.

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