Biogen announced that the European Commission has granted marketing authorization for a high‑dose regimen of its spinal muscular atrophy therapy SPINRAZA (nusinersen). The new schedule consists of two 50 mg loading doses given 14 days apart, followed by 28 mg maintenance doses every four months, replacing the existing 12 mg regimen for patients who transition from the low‑dose schedule.
The approval is based on the Phase 2/3 DEVOTE study, which enrolled 145 participants and demonstrated statistically significant improvements in motor function for treatment‑naïve infants and meaningful gains for patients switching from the low‑dose regimen. Safety data were consistent with the 12 mg regimen, with no new safety concerns reported in the long‑term extension.
By expanding SPINRAZA’s dosing options, the approval broadens the drug’s addressable market in the European Union and simplifies treatment logistics for clinicians and patients. The higher‑dose regimen is expected to increase uptake among patients who previously required more frequent dosing, potentially boosting sales volume and reinforcing Biogen’s leadership in the rare‑disease segment.
Priya Singhal, M.D., M.P.H., Executive Vice President and Head of Development, said, “Since its EU approval in 2017, SPINRAZA has set a new standard in patient care and treated more than 10,000 infants, children, teens and adults worldwide. We are proud to introduce the high‑dose regimen, which we have developed to address the evolving needs of individuals living with SMA, and are deeply committed to bringing it to the European SMA community as quickly as possible.”
The high‑dose regimen is also under review by the U.S. Food and Drug Administration, where a decision is expected by April 3 2026. The FDA previously issued a Complete Response Letter requesting updates to the chemistry, manufacturing and controls module, but did not cite deficiencies in the clinical data, suggesting that the U.S. approval path is likely to proceed once the requested updates are submitted.
Biogen’s broader portfolio includes multiple sclerosis, Alzheimer’s disease, and other rare‑disease therapies. In the most recent quarter, the company’s rare‑disease segment drove revenue growth, offsetting headwinds in its legacy multiple‑sclerosis franchise. The company’s “Fit for Growth” initiative continues to focus on cost discipline and strategic investments, positioning it to capitalize on the expanded SPINRAZA offering while maintaining financial resilience.
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