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US FDA gives a thumbs up to Entyvio
US FDA gives a thumbs up to Entyvio

US FDA gives a thumbs up to Entyvio

The U.S. Food and Drug Administration Tuesday approved Entyvio (vedolizumab) injection to treat adult patients with moderate to severe ulcerative colitis and adult patients with moderate to severe Crohn’s disease.

Entyvio is approved to treat those conditions when one or more standard therapies (corticosteroids, immunomodulators, or tumor necrosis factor blocker medications) have not resulted in an adequate response.

The safety and efficacy of Entyvio for ulcerative colitis were established in 2 studies that enrolled about 900 patients with inadequate response to corticosteroids, immunomodulators, or TNF-blockers. Patients were evaluated for measures of stool frequency, rectal bleeding, endoscopic findings, and a physicians’ overall assessment.

Data showed that a greater percentage of subjects treated with Entyvio achieved and maintained a clinical response, achieved and maintained clinical remission, achieved corticosteroid-free clinical remissions, and had improved colon appearance as seen during endoscopy, compared to placebo.

Entyvio was also studied in 3 trials that enrolled about 1500 patients with Crohn’s disease who had inadequate response to corticosteroids, immunomodulators, or TNF-blockers. A greater percentage of subjects treated with Entyvio achieved clinical response, achieved clinical remission, and achieved corticosteroid-free clinical remission compared to placebo.

Entyvio is an integrin receptor antagonist that blocks the interaction of a specific integrin receptor with a specific protein. This results in a migration block of the circulating inflammatory cells across blood vessels and into areas of inflammation in the gastrointestinal tract.

Entyvio injection will be available in 300mg single-dose vials. The product is expected to launch in early June 2014.

Agencies/Canadajournal




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