Biogen Spinraza Approval: The Perfect Antidote To Sarepta Headlines?

The US FDA’s Dec. 23 approval of Biogen Inc./Ionis Pharmaceuticals Inc.’s Spinraza (nusinersen) for the rare neurological disease spinal muscular atrophy (SMA) may be the perfect antidote to the bad feelings that followed the difficult and internally divisive approval of Sarepta Therapeutics Inc.’s Exondys 51 (eteplirsen) by the same review group at FDA.

In a year marked by a steep drop in NME approvals (22 vs. 45), a jump in Complete Response letters for NMEs (13 vs. 2), and the spectacle of internal discord over Exondys 51, the Spinraza approval is an almost-too-good-to-be-true example of the recent new drug review climate at its best