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Biogen: EMA and FDA examine an enhanced dosage of Spinraza
(CercleFinance.com) - Biogen announces that the European Medicines Agency (EMA) has agreed to review the marketing authorization application for a higher dosage regimen of nusinersen (Spinraza) in the treatment of spinal muscular atrophy (SMA).
In addition, the US FDA has agreed to review the New Drug Application (sNDA) for this same nusinersen regimen, in the same indication. The higher-dose nusinersen regimen includes a faster loading dose, two 50 mg doses 14 days apart, and a higher maintenance dose, 28 mg, every 4 months, compared with the approved nusinersen regimen. We are pleased to announce that our applications for the higher dosage regimen of nusinersen are now under review in Europe and the US, Biogen's Neuromuscular Disease Development Unit said. Nusinersen is currently marketed under the brand name Spinraza in over 71 countries at the approved dose of 12 mg. Copyright (c) 2025 CercleFinance.com. All rights reserved. |
11/04/2025 17:33
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