By Colin Kellaher

Biogen said U.S. and European regulators will review its applications seeking approval of a higher-dose regimen of its Spinraza drug for the neuromuscular disease spinal muscular atrophy.

The Cambridge, Mass., biotechnology company on Thursday said the higher-dose Spinraza treatment includes a faster loading regimen and a higher maintenance regimen that the currently approved regimen.

Biogen said the U.S. Food and Drug Administration has accepted its supplemental new-drug application, while the European Medicines Agency has validated its application, which confirms that the submission is complete and starts the EMA's centralized review process.

Biogen said the applications are based on a Phase 2/3 study that showed the higher-dose regimen can enable meaningful clinical benefits while maintaining a safety profile broadly consistent with the currently approved regimen.

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 $1.15 billion for the first nine months of 2024. 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 23, 2025 07:57 ET (12:57 GMT)

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