Spevigo (spesolimab)
ConditionalAdditional monitoring
- Region
- 🇪🇺 EU
- Active substance
- spesolimab
- Company
- LEO Pharma A/S
- Status
- Authorised
- Therapeutic area
- Psoriasis
- CHMP opinion
- Thu 13 Oct 2022
- EU approval
- Fri 09 Dec 2022
- Designations
- Conditional, Additional monitoring
- Application
- EMEA/H/C/005874
- ATC
- L04AC22
- Official record
- www.ema.europa.eu
Indication
Spevigo is indicated for the prevention of generalised pustular psoriasis (GPP) flares in adults and adolescents from 12 years of age. Spevigo is indicated for the treatment of generalised pustular psoriasis (GPP) flares in adults and adolescents from 12 years of age as monotherapy.
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.