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Biogen Gets FDA OK of High-Dose Spinraza Regimen

Provided by Dow Jones Mar 30, 2026, 12:12:00 PM

By Colin Kellaher

Biogen has won U.S. Food and Drug Administration approval for a high-dose regimen of its Spinraza drug for the neuromuscular disease spinal muscular atrophy.

Biogen on Monday said it expects the high-dose regimen of Spinraza, which is already approved in the European Union, Switzerland and Japan, will be available in the U.S. in the coming weeks.

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.

Spinraza generated worldwide sales of nearly $1.55 billion last year. 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

March 30, 2026 08:12 ET (12:12 GMT)

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