Dec 9 An advisory panel of medical experts on
Monday voted to recommend that U.S. health regulators approve an
experimental drug for ulcerative colitis and Crohn's disease
developed by Takeda Pharmaceutical Co.
There were specific safety and efficacy questions for each
of the two conditions put before the panel. It ultimately found
by wide margins that the benefits outweigh the risks of the
biotech drug, vedolizumab, and advised the Food and Drug
Administration to approve it for ulcerative colitis and Crohn's
disease in patients who have not been helped by prior therapies.
The FDA typically follows the recommendations of its expert
advisory panels but is not obligated to do so.