Japan’s Takeda says that its Millennium Pharmaceuticals unit has initiated two Phase III clinical trials for vedolizumab, its investigational compound for inflammatory bowel disease.

Vedolizumab, codenamed MLN0002, is a novel alpha-4 beta-7 integrin antagonist, a highly selective humanised monoclonal antibody. Takeda notes that it works by blocking a key inflammatory marker on white blood cells, “thereby preventing the migration of these inflammatory cells into the intestinal wall”.

The trials, known as the Gemini programme, will study vedolizumab for the treatment of ulcerative colitis and Crohn's disease, the two main types of IBD. The two studies will enroll nearly 2,000 patients in more than 40 countries and each trial consists of a six-week induction phase followed by 46 weeks of maintenance therapy. Vedolizumab will be administered as an intravenous infusion.

Dosing of the first patient in the Phase III development program of vedolizumab is an exciting milestone," said Brian Feagan, professor of medicine at the University of Western Ontario, London, Canada and principal investigator of the Gemini studies. Takeda noted that failure of current medical therapy for UC and Crohn's disease frequently leads to surgical removal of the colon and multiple bowel resections, respectively.

Nancy Simonian, chief medical officer of Millennium, noted that unlike existing therapies, “the unique gut-selective targeting of vedolizumab has the potential to benefit IBD patients without compromising systemic immune function."

Febuxostat PDUFA date missed by FDA
Less good news for Takeda came with the announcement that the US Food and Drug Administration would not be able to complete its review of the New Drug Application for the gout drug febuxostat by the Prescription Drug User Fee Act (PDUFA) date of January 18.

Dean Sundberg, senior vice president of regulatory affairs at Takeda Global Research & Development Center in the USA, noted that the “FDA raised no issues with the NDA submission or the data included in it”. Instead the agency acknowledged that the PDUFA date would be missed “due to its inability to complete routine inspections at investigator sites” and at a clinical research organisation involved in the development of febuxostat.

He added that Takeda has provided all necessary information at this point in the NDA review process” and looks forward to receiving a final approval date for febuxostat. The drug, a once-daily, oral treatment of hyperuricemia in patients with gout, was recommended for approval in November by FDA's Arthritis Advisory Committee by a vote of 12-0 with one panel member abstaining. Takeda licensed febuxostat from Teijin Pharma.