Biogen Receives European Commission Approval for High Dose Regimen of SPINRAZA® (nusinersen) for Spinal Muscular Atrophy

About this update from Biogen Inc.

[{"type":"image","alt":"Biogen Inc.","displaySize":"","headline":null,"caption":"Biogen Inc.","className":"","disableSlideshowImg":false,"size":{"original":{"width":300,"height":101,"url":"https://media.zenfs.com/en/globenewswire.com/d780d0e9a7ba00777730acf271f9e937"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/wH5zYbm3mC0cXQRHhCXgVw--/YXBwaWQ9aGlnaGxhbmRlcjt3PTQyMDtoPTE0MTtjZj13ZWJw/https://media.zenfs.com/en/globenewswire.com/d780d0e9a7ba00777730acf271f9e937","width":300,"height":101}},"lazy":false},{"type":"list","items":[{"val":[{"type":"text","content":"Approval is supported by data from the DEVOTE study which showed the benefit of the SPINRAZA 50 mg and 28 mg regimen in both treatment-naïve and previously-treated nusinersen patients with SMA1","length":193,"tagName":"p"}]},{"val":[{"type":"text","content":"Biogen is dedicated to partnering with the SMA community to advance care through scientific innovation and a commitment to enhancing outcomes for people living with SMA","length":168,"tagName":"p"}]}],"tagName":"ul","bulletedList":true,"length":361,"olType":false},{"type":"text","content":"CAMBRIDGE, Mass., Jan. 12, 2026 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) today announced the European Commission (EC) has granted marketing authorization for a high dose regimen of SPINRAZA® (nusinersen) which is comprised of 50 mg/5 mL and 28 mg/5 mL doses for the treatment of 5q spinal muscular atrophy (SMA). 5q SMA is the most common form of the disease and represents approximately 95% of all SMA cases.2 The SPINRAZA European Union marketing authorization has been updated to include the high dose regimen. The new high dose regimen comprises a more rapid loading phase, two 50 mg loading doses administered 14 days apart and 28 mg maintenance dose injections every four months thereafter. Individuals transitioning from the 12 mg dose will receive one 50 mg dose in place of their next 12 mg dose, followed by 28 mg maintenance doses every four months thereafter. SPINRAZA is for intrathecal use by lumbar puncture by health care professionals experienced in performing lumbar punctures.","length":1001,"tagName":"p"},{"type":"text","content":"“Since its approval in the European Union in 2017, SPINRAZA has helped set a new standard in patient care and treated more than then 10,000 infants, children, teens and adults worldwide,” Priya Singhal, M.D., M.P.H.,...

More updates from Biogen Inc.