07:51 AM EST, 11/17/2025 (MT Newswires) -- Biogen (BIIB) said Monday the European Medicines Agency's Committee for Medicinal Products for Human Use has recommended approval of a high dose regimen of nusinersen for the treatment of 5q spinal muscular atrophy.

The CHMP's positive opinion will now be reviewed by the European Commission, with a final decision expected in January, the company said, adding that if approved, the high dose regimen will be an additional dosing option to the currently approved 12 mg low dose regimen.

Biogen said the CHMP opinion is based on data from a phase 2/3 study and its ongoing long-term extension, which assessed the efficacy and safety of the high dose regimen in both treatment-naive and individuals previously-treated with the approved 12 mg dosing regimen.