Spinraza (nusinersen)
- Region
- 🇪🇺 EU
- Active substance
- nusinersen
- Company
- Biogen Netherlands B.V.
- Status
- Authorised
- Therapeutic area
- Muscular Atrophy, Spinal
- CHMP opinion
- Fri 21 Apr 2017
- EU approval
- Tue 30 May 2017
- Designations
- Orphan, Accelerated assessment
- Application
- EMEA/H/C/004312
- ATC
- M09
- Official record
- www.ema.europa.eu
Indication
Spinraza is indicated for the treatment of 5q Spinal Muscular Atrophy.
Regulatory milestones
SPINRAZA: PDUFA target action date (spinal muscular atrophy (high dose))
Ionis Pharmaceuticals Inc (IONS); nusinersen; empty; status: set; "(PDUFA date of April 3, 2026) o Positive high dose results from pivotal DEVOTE study published in Nature Medicine • WAINUA ® (eplontersen) (WAINZUA"; filed 2026-02-25 · source
SPINRAZA: PDUFA target action date (high dose regimen)
Biogen Inc. (BIIB); status: set; "FDA PDUFA of April 3, 2026 • BTK degrader (BIIB145) targeting autoimmune diseases Phase 1 study initiated in healthy volunteers Full year 2026 fin"; filed 2026-02-06 · source
Follow Spinraza
Get VigiEye Daily: approvals, opinions, safety actions and PDUFA dates every morning.
Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.