Takeda receives positive CHMP opinion for vedolizumab IV for the treatment of active chronic pouchitis.
The CHMP opinion will now be reviewed by the European Commission. If approved, vedolizumab will become the first treatment indicated for active chronic pouchitis across the European Union.
Pouchitis is a major complication after proctocolectomy with IPAA in UC patients. Although acute pouchitis may respond to antibiotic therapy, antibiotic-refractory pouchitis, where the condition does not adequately respond to antibiotic therapy, can result in frequent relapses. Antibiotic-refractory pouchitis affects 10-15% of patients with pouchitis globally, and can have a considerable impact on their quality of life.
The positive opinion from the CHMP was based on the EARNEST trial, recently presented at the United European Gastroenterology’s annual meeting, UEG Week Virtual 2021, which assessed the safety and efficacy of vedolizumab IV in the treatment of active chronic pouchitis. Moreover, information from a number of retrospective studies of historical data indicating that vedolizumab can have a positive impact on patients with inflammation of the pouch was also included in the application.
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Takeda Pharmaceutical Company Limited announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the approval of intravenous (IV) vedolizumab for the treatment of adult patients with moderately to severely active chronic pouchitis, who have undergone proctocolectomy and ileal pouch-anal anastomosis (IPAA) for ulcerative colitis (UC), and have had an inadequate response with or lost response to antibiotic therapy.