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Takeda's IBD drug backed by FDA panel

  • Takeda's (TKPHF +1.4%) vedolizumab had a rather easy go of it Monday, as an FDA panel voted overwhelmingly that the drug should be approved as a maintenance therapy for Crohn's disease and as a treatment for Crohn's and ulcerative colitis in patients not helped by prior therapies.
  • Nevertheless, the vote was far closer (12-9) regarding whether the treatment should be available as an early therapy.
  • "The FDA's efficacy concerns stem from some up-and-down data in vedolizumab's pivotal trials," FierceBiotech's Damien Garde notes, before adding that, on the bright side, "the panel voted 21-0-0 that the company had adequately characterized the drug's risks of PML."
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