Evrysdi (risdiplam)
PRIMEAccelerated assessment
- Region
- 🇪🇺 EU
- Active substance
- risdiplam
- Company
- Roche Registration GmbH
- Status
- Authorised
- Therapeutic area
- Muscular Atrophy, Spinal
- CHMP opinion
- Thu 25 Feb 2021
- EU approval
- Fri 26 Mar 2021
- Designations
- PRIME, Accelerated assessment
- Application
- EMEA/H/C/005145
- ATC
- M09AX10
- Official record
- www.ema.europa.eu
Indication
Evrysdi is indicated for the treatment of 5q spinal muscular atrophy (SMA) in patients with a clinical diagnosis of SMA Type 1, Type 2 or Type 3 or with one to four SMN2 copies.
Regulatory milestones
Fri 12 Jun 2026🇪🇺 DHPC safety letter
Evrysdi (risdiplam): DHPC sent to healthcare professionals
Quality defect; Muscular Atrophy, Spinal · source
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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.