European Commission Approves High Dose Regimen of SPINRAZA for Spinal Muscular Atrophy

Reuters01-13

European Commission Approves High Dose Regimen of SPINRAZA for Spinal Muscular Atrophy

Biogen Inc. has announced that the European Commission has granted marketing authorization for a high dose regimen of SPINRAZA® (nusinersen) for the treatment of 5q spinal muscular atrophy $(SMA)$, the most common form of the disease. The new regimen includes a more rapid loading phase with two 50 mg doses administered 14 days apart, followed by 28 mg maintenance doses every four months. This approval is supported by data from the DEVOTE study and updates the SPINRAZA European Union marketing authorization to include the high dose regimen. The high dose regimen is also approved in Japan and is currently under review by the U.S. Food and Drug Administration, with a decision expected by April 3, 2026.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Biogen Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: GNW9623994-en) on January 12, 2026, and is solely responsible for the information contained therein.

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The new regimen includes a more rapid loading phase with two 50 mg doses administered 14 days apart, followed by 28 mg maintenance doses every four months. This approval is supported by data from the DEVOTE study and updates the SPINRAZA European Union marketing authorization to include the high dose regimen. The high dose regimen is also approved in Japan and is currently under review by the U.S. Food and Drug Administration, with a decision expected by April 3, 2026.\n      \n\n\nDisclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Biogen Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. 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