Regulators in the USA have given the green light to Takeda Pharmaceutical Co's Entyvio for two inflammatory bowel diseases.

The US Food and Drug Administration has simultaneously approved Entyvio (vedolizumab) for the treatment of adults with moderately to severely active ulcerative colitis and Crohn's disease. The drug can be used for those conditions when one or more standard therapies (corticosteroids, immunomodulators or tumour necrosis factor blocker medications) have failed.

It was back in December that a joint panel of members from the agency's Gastrointestinal Drugs and Drug Safety and Risk Management Advisory Committees voted to recommend approval. In Europe, Entyvio received a positive opinion for the two conditions from the Committee for Medicinal Products for Human Use in March.

Entyvio is an integrin receptor antagonist, in the same class as Biogen Idec's multiple sclerosis drug Tysabri (natalizumab) which is been associated with the rare and often fatal brain infection, progressive multifocal leukoencephalopathy. The FDA noted that there were no cases reported of PML among the 2,700 patients in the trials and participants were monitored and regularly screened for the infection.

Nevertheless, the agency said that "there remains uncertainty regarding the risk of PML", adding that doctors should monitor patients on Entyvio "for any new onset, or worsening, of neurological signs and symptoms". The FDA is also requiring Takeda to conduct a post-marketing study "and enhanced, expedited adverse event reporting".
Amy Egan, acting deputy director of the Office of Drug Evaluation III in the FDA’s Center for Drug Evaluation and Research, stated that although there is no cure for these conditions, the approval "provides an important new treatment option for patients who have had an inadequate response to conventional therapy".