Takeda’s Inflammatory Bowel Medicine Wins EU Regulatory Backing

EU Regulatory Backing, A European Medicines Agency committee backed Takeda Pharmaceutical Co.’s (4502) treatment for 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.

Read: Takeda’s Inflammatory Bowel Medicine

About Robert Hill

I founded IDEAS Intestinal Disease Education and Awareness Society, from my home base in Vancouver, British Columbia. Intestinal Disease Education and Awareness Society IDEAS is established to raise public awareness of intestinal diseases in order to help remove the stigmas associated with these illnesses. The programs of IDEAS help children, youth and young adults learn to live full lives, find acceptance and gain confidence.

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