Takeda’s Inflammatory Bowel Medicine Wins EU Regulatory Backing, A European Medicines Agency committee backed Takeda Pharmaceutical Co.âs (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.