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Biogen's nusinersen marketing applications accepted for review in U.S. and Europe

Published 10/28/2016, 09:44 AM
Updated 10/28/2016, 09:44 AM
Biogen's nusinersen marketing applications accepted for review in U.S. and Europe
  • The FDA accepts under Priority Review Biogen's (NASDAQ:BIIB -1.3%) New Drug Application (NDA) seeking approval of nusinersen for the treatment of spinal muscular atrophy (SMA). The European Medicines Agency has done the same, accepting the company's Marketing Authorization Application (MAA) under Accelerated Assessment status. Both shorten the review clock.
  • SMA is an inherited disorder characterized by the loss of motor neurons in the spinal cord and lower brain stem, leading to severe and progressive muscular atrophy and weakness. It is caused by a defect in or loss of the SMN1 gene which results in the insufficient production of survival motor neuron protein, essential for maintenance of motor neurons.
  • Nusinersen is an antisense drug designed to correct the splicing defect that causes SMA by increasing the production of fully functional SMN protein. Biogen licensed it from Ionis Pharmaceuticals (IONS -0.7%) under their 2012 collaboration agreement. If approved, Ionis could earn up to $225M in total milestones in addition to mid-teen royalties.
  • Biogen intends to market nusinersen under the brand name SPINRAZA.

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