Velsipity (etrasimod)
Additional monitoring
- Region
- 🇪🇺 EU
- Active substance
- etrasimod
- Company
- Pfizer Europe MA EEIG
- Status
- Authorised
- Therapeutic area
- Colitis, Ulcerative
- CHMP opinion
- Thu 14 Dec 2023
- EU approval
- Fri 16 Feb 2024
- Designations
- Additional monitoring
- Application
- EMEA/H/C/006007
- ATC
- L04AE05
- Official record
- www.ema.europa.eu
Indication
Velsipity is indicated for the treatment of patients 16 years of age and older with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, lost response, or were intolerant to either conventional therapy, or a biological agent.
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.