Takeda overcomes safety questions, wins FDA OK for IBD drug vedolizumab

After running a gamut of regulatory challenges on vedolizumab's safety profile, Takeda has emerged on the other side with an agency approval to market the drug--as Entyvio--for inflammatory bowel diseases.

Physicians will soon have an option to use Entyvio as a second-line therapy for ulcerative colitis and Crohn's disease, a restriction that is likely to seriously blunt its market value.

"Ulcerative colitis and Crohn's disease are debilitating diseases that impact the quality of life of those who have these conditions," said Amy Egan, the acting deputy director of the Office of Drug Evaluation III in the FDA's Center for Drug Evaluation and Research. "Although there is no cure for these conditions, today's approval provides an important new treatment option for patients who have had an inadequate response to conventional therapy to help control their symptoms."

Late last year the agency's internal review noted the drug's proven efficacy--though the trial process was anything but smooth, seeing some setbacks on primary and secondary endpoints along the way--but red-flagged a risk for potentially lethal cases of progressive multifocal leukoencephalopathy, or PML. There were no actual cases of PML reported in the drug studies, but the therapy's similarities to Biogen Idec's ($BIIB) Tysabri, which has sparked a number of cases of PML, was a cause for concern. Takeda, though, felt that there were enough mechanistic differences to sufficiently reduce the risks involved.

A clear majority of the FDA's outside experts had agreed that the drug, when used with immunosuppressants, was safe enough. But they had split over whether the drug should be used as a front-line induction therapy, with most agreeing that it worked as a maintenance drug.

Like Tysabri, Entyvio is an integrin receptor antagonist, blocking the migration of inflammatory cells behind these two common inflammatory bowel conditions.

One prominent patients group noted that today's approval marked a real advance for patients.

"Not only does it provide a new option for those who may have stopped responding to or were intolerant to other conventional therapies, but it is the first treatment designed specifically to target receptors in the gut," said Caren Heller, the CSO at the Crohn's & Colitis Foundation of America. "It is a drug with a new mechanism of action, which could be very important for improving  the lives of so many."

For now, though, there's no word on price.

"It is not Takeda's policy to disclose this information with regard to our products, but we aim to set prices that are both competitive and flexible," says Takeda in response to a query from FierceBiotech, by way of not commenting.

- here's the FDA's release