European Commission Approves Takeda’s Crohn’s Disease Drug Entyvio

The European Commission has given Takeda Pharmaceutical approval to market Entyvio for the treatment of ulcerative colitis (UC) and Crohn’s disease (CD) in patients that have inadequate responses to conventional therapy, the company said.

The intravenous infusion, administered at a variety of times over many weeks, is the first and only biological treatment that simultaneously treats patients with either moderate to severe UC or moderate to severe CD, Takeda said May 27. European approval follows the FDA’s May 20 clearance.

UC and CD affect more than 4 million people worldwide and are the two most common types of inflammatory bowel disease.

“The approval of vedolizumab (Entyvio) in Europe is an important step forward in the treatment of ulcerative colitis and Crohn’s disease,” said Paul Rutgeerts, M.D., Ph.D., and former professor of medicine at Catholic University of Leuven.

Trevor Smith, head of Takeda’s commercial operations in Europe and Canada, said he was pleased that the European Commission recognizes the drug’s clinical benefit, and that Takeda is committed to expanding the range of therapeutic options available for the patient community.

Other treatments for Crohn’s disease such as Tysabri have increased the risk of progressive multifocal leukoencephalopathy (PML), a viral brain disease that cause severe disability or death. While no cases of PML were seen among patients participating in Entyvio clinical trials, there remains uncertainty regarding the risk of PML in patients taking the drug, the FDA said. — Harry Morrison

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