Nusinersen high-dose PDUFA Date (Biogen)
FDA PDUFA decision date for Nusinersen high-dose is April 3, 2026. Developed by Biogen. Indication: Spinal muscular atrophy (SMA) — high-dose regimen. Current status: Approved.
Indication
Spinal muscular atrophy (SMA) — high-dose regimen
Notes
Resubmission after CRL. Higher dose of Spinraza for SMA patients.
Regulatory details
- Company: Biogen
- Therapeutic area: Rare Disease / Neurology
- Application type: sNDA
- Review type: Priority
- PDUFA date: 2026-04-03
- Outcome: Approved