Nusinersen Gets Priority Review from FDA
- By Laurie Watanabe
- Nov 04, 2016
Nusinersen, a drug to treat spinal muscular atrophy (SMA), has received priority review status from the U.S. Food & Drug Administration (FDA), according to Cure SMA.
Cure SMA, an organization focusing on research to find treatments and a cure for the genetic condition, said the FDA news was announced by Biogen, nusinersen’s manufacturer.
Biogen also said its Marketing Authorization Application has been validated by the European Medicines Agency, meaning, Cure SMA said, that “the regulatory review process for these applications has now been initiated in the U.S. and European Union (EU).”
In its news announcement, Cure SMA said the time needed for American and European agencies to review nusisersen could be reduced thanks to the drug’s priority review status.
If nusisersen is approved for use, it would become the first therapy for SMA, which is the world’s leading genetic cause of death in infants.
Laurie Watanabe is the editor of Mobility Management. She can be reached at firstname.lastname@example.org.