By Colin Kellaher

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

Biogen on Monday said the positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use covers the high-dose regimen of Spinraza for the treatment of 5q SMA, which represents about 95% of all SMA cases.

The European Commission, which generally follows CHMP's advice, will now review the recommendation, with a decision expected in January, the Cambridge, Mass., biotechnology company said.

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

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 $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

November 17, 2025 06:40 ET (11:40 GMT)

Copyright (c) 2025 Dow Jones & Company, Inc.