NasdaqGS:BIIBBiotechs
The Bull Case For Biogen (BIIB) Could Change Following EU Approval Of High‑Dose Spinraza Regimen
Biogen recently received European Commission marketing authorization for a high-dose SPINRAZA regimen to treat 5q spinal muscular atrophy, covering rapid-loading 50 mg doses followed by 28 mg maintenance injections every four months.
This decision, grounded in the DEVOTE Phase 2/3 trial showing statistically significant motor function gains with a safety profile consistent with nusinersen, meaningfully broadens treatment options for the vast majority of SMA patients in Europe.
We’ll now...