Biogen Gets European Approval of Higher-Dose Spinraza

Dow Jones01-13

By Colin Kellaher

Biogen has secured European regulatory approval for a high-dose regimen of its Spinraza drug for the neuromuscular disease spinal muscular atrophy, or SMA.

Biogen on Monday said the European Commission approved the high-dose regimen of Spinraza for the treatment of 5q SMA, which represents about 95% of all SMA cases.

Spinal muscular atrophy is a rare genetic disease characterized by a loss of motor neurons in the spinal cord and lower brain stem, resulting in severe, progressive muscle atrophy and weakness.

The U.S. Food and Drug Administration is reviewing Biogen's application for the high-dose regimen, with a decision due by early April.

Spinraza generated worldwide sales of $1.19 billion for the first nine months of 2025. Biogen licensed the global rights to develop, manufacture and commercialize Spinraza from Ionis Pharmaceuticals, which receives royalties on sales of the drug.

Write to Colin Kellaher at colin.kellaher@wsj.com

(END) Dow Jones Newswires

January 12, 2026 11:22 ET (16:22 GMT)

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