Takeda Inflammatory Bowel Drug Wins EU Regulatory Backing

A European Medicines Agency committee backed Takeda Pharmaceutical Co.’s (4502) treatment for ulcerative colitis and Crohn’s disease.

The Committee for Medicinal Products for Human Use recommended granting marketing authorization for Entyvio for adults who didn’t respond to or couldn’t tolerate other treatments, the London-based regulator said today in a statement. The European Commission usually follows the panel’s advice.

The treatment, also known as vedolizumab, is being reviewed by the U.S. Food and Drug Administration for both indications. A decision on its use in ulcerative colitis is expected by May 20 and for Crohn’s disease by June 18. An advisory panel recommended the drug be approved for both illnesses even after FDA staff raised concerns about the risk of a deadly brain infection.

Among patients with ulcerative colitis who took Takeda’s intravenous drip vedolizumab for a year, at least 40 percent had a temporary end to symptoms compared with those who took placebo for the same period, according to a study published last year in the New England Journal of Medicine. A separate study found the drug helped Crohn’s patients reach remission after a year of treatment, compared with those on placebo.

Inflammatory bowel diseases are chronic with no cure and are more common in industrialized countries though there is thought to be a strong genetic link, according to the Centers for Disease Control and Prevention.

For Related News and Information: Takeda Announces Extension of FDA PDUFA Action

To contact the reporter on this story: Allison Connolly in London at aconnolly4@bloomberg.net

To contact the editors responsible for this story: Phil Serafino at pserafino@bloomberg.net Robert Valpuesta

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