Biogen Receives European Commission Approval for High Dose SPINRAZA

The European Commission approved a high dose regimen of SPINRAZA (nusinersen), Biogen announced on January 12, 2026.

Biogen announced that the European Commission has approved a high dose regimen of SPINRAZA (nusinersen) for spinal muscular atrophy. The announcement appeared as a company news release dated January 12, 2026. SPINRAZA is marketed by Biogen under the generic name nusinersen. The release contains standard forward-looking language that outlines risks and uncertainties related to drug development and commercialization. Key points: - The European Commission approved a high dose regimen of SPINRAZA (nusinersen). - Biogen published the announcement on January 12, 2026. - The company’s news release includes forward-looking statements about potential benefits, risks, and regulatory or commercial outcomes. - Those forward-looking statements are described as subject to uncertainties and not guarantees of future results. Summary: The approval is a regulatory decision affecting a higher-dose SPINRAZA regimen in the European Union and is presented by Biogen alongside cautionary forward-looking language. Undetermined at this time.