Entyvio (vedolizumab)
- Region
- 🇪🇺 EU
- Active substance
- vedolizumab
- Company
- Takeda Pharma A/S
- Status
- Authorised
- Therapeutic area
- Colitis, Ulcerative; Crohn Disease
- CHMP opinion
- Thu 20 Mar 2014
- EU approval
- Thu 22 May 2014
- Application
- EMEA/H/C/002782
- Official record
- www.ema.europa.eu
Indication
Ulcerative colitis Entyvio is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a tumour necrosis factor alpha (TNF?) antagonist. Crohn’s disease Entyvio is indicated for the treatment of adult patients with moderately to severely active Crohn’s disease who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a tumour necrosis factor alpha (TNF?) antagonist. Pouchitis Entyvio is indicated for the treatment of adult patients with moderately to severely active chronic pouchitis, who have undergone proctocolectomy and ileal pouch anal anastomosis for ulcerative colitis, and have had an inadequate response with or lost response to antibiotic therapy.
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.