This article is more than 5 years old. Information may no longer be current.
Vedolizumab enters phase 3 trials for treating IBD
Click Here to Manage Email Alerts
Two new clinical trials have begun to collect additional data regarding the safety and efficacy of vedolizumab as an induction and maintenance therapy for treatment of ulcerative colitis and Crohn’s disease, Takeda Pharmaceutical announced in a news release.
The placebo-controlled, multicenter, randomized, double blind, parallel-group phase 3 trials are being conducted in Japan. Primary endpoints are the rates of clinical response (induction phase) and clinical remission (maintenance phase) after 10 and 60 weeks, respectively.
Vedolizumab is a humanized monoclonal antibody designed to antagonize the alpha4beta7 integrin and limit the ability of certain lymphocytes to infiltrate gut tissues.
Vedolizumab, which Takeda hopes to market under the name Entyvio, received initial backing from the FDA’s Gastrointestinal Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee in December. The FDA’s final decisions on its use among ulcerative colitis and Crohn’s disease patients are expected by mid-year.
Takeda also has submitted an authorization application seeking approval to market vedolizumab in the European Union.
The new studies are intended to “accelerate the development of this drug to deliver this effective and highly anticipated treatment option for patients in Japan,” Asit Parikh, MD, PhD, vice president of general medicine for Takeda, said in the release.