FDA advisory committee recommends approval for Takeda's vedolizumab

Drug maker seeks approval for vedolizumab in ulcerative colitis, Crohn's disease

DEERFIELD, Ill. — An expert panel at the Food and Drug Administration has given a thumbs-up to an experimental drug made by Takeda Pharmaceutical Co. for treating ulcerative colitis and Crohn's disease, the drug maker said.

Takeda said the FDA's Gastrointestinal Drugs and Drug Safety and Risk Management Advisory Committee voted in favor of approval for vedolizumab in adults with moderately to severely active UC or Crohn's. A favorable advisory committee vote does not guarantee FDA approval of a drug, but the agency usually follows the votes when deciding whether or not to grant approval.

"People with ulcerative colitis or Crohn's disease are in need of additional treatment options, as many patients lose response to currently available treatments," Takeda VP general medicine Asit Parikh said. "Vedolizumab was designed to treat inflammation of the [gastrointestinal] tract and, if approved, may offer an additional option for patients suffering from ulcerative colitis or Crohn's disease."


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