Biogen (BIIB) announced Thursday that the US Food and Drug Administration has accepted its supplemental new drug application and that the European Medicines Agency has validated the application for a higher dose regimen of its experimental drug, nusinersen, for spinal muscular atrophy.
The company said it would study the efficacy of a higher dose regimen, including two 50 mg doses given 14 days apart and a maintenance dose of 28 mg every four months, compared to the currently approved regimen.
Nusinersen, marketed as Spinraza, is available in over 71 countries at the approved 12 mg dose, it added.
Biogen licensed the global rights to develop and commercialize Spinraza from Ionis Pharmaceuticals (IONS).
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