Biogen (NASDAQ:BIIB) said the FDA approved a higher-dose regimen of its SPINRAZA (nusinersen) therapy for patients with spinal muscular atrophy (SMA).
The regimen includes two 50 mg/5 mL loading doses followed by maintenance doses of 28 mg/5 mL administered every four months.
The approval was supported by data from the Phase 2/3 DEVOTE study, which demonstrated a mean improvement of 26.19 points on the Children’s Hospital of Philadelphia Infant Test of Neuromuscular Disorders (CHOP-INTEND) score in the high-dose arm compared with a matched sham control group (p<0.0001).
The high-dose regimen of SPINRAZA is also approved in the European Union, Switzerland, and Japan.
The therapy will be made available to patients in the United States in the coming weeks.