Enspryng (satralizumab)
Orphan
- Region
- 🇪🇺 EU
- Active substance
- satralizumab
- Company
- Roche Registration GmbH
- Status
- Authorised
- Therapeutic area
- Neuromyelitis Optica
- CHMP opinion
- Thu 22 Apr 2021
- EU approval
- Thu 24 Jun 2021
- Designations
- Orphan
- Application
- EMEA/H/C/004788
- ATC
- L04AC
- Official record
- www.ema.europa.eu
Indication
Satralizumab (Enspryng) is indicated as a monotherapy or in combination with immunosuppressive therapy (IST) for the treatment of neuromyelitis optica spectrum disorders (NMOSD) in adult and adolescent patients from 12 years of age who are anti-aquaporin-4 IgG (AQP4-IgG) seropositive.
Regulatory milestones
No milestones recorded in the last year.
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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.