Wednesday, May 21, 2014

The FDA has approved Entyvio (vedolizumab) for the treatment of UC and CD

  • Approval is for UC and CD when one or more standard therapies (corticosteroids, immunomodulators, or TNFis) have not resulted in an adequate response.  The exact indications are depicted below
  • For UC, the indication is for the induction and maintenance of response or remission
  • For CD, the label is slightly different, avoiding the use of the words "induction" or "maintaining" preferring the word achieving
  • As expected the label does not carry a boxed warning of "JCV infection resulting in PML" as is the case for Tysabri.  The FDA does however recommend HCPs to monitor patients on Entyvio for any new onset, or worsening, of neurological signs and symptoms
  • Importantly, the label does not carry boxed warnings of malignancy or serious infection
Comments:  The wording of the CD indication deserves mention.  Specifically, the word "achieving" rather than "inducing" or "maintaining" in the context of remission is used.  This is different from both Remicade and Humira label which have the indications of "inducing and maintaining clinical remission".  We will be evaluating the implications of this, if any.  Importantly, the label allows for the use of vedolizumab either before steroids or TNFis.  The latter is important as the vedolizumab label does not carry a boxed warning of serious infection (or malignancy).  Vedolizumab may therefore find a niche in patients at risk of either, as well as in patients who have not responded sufficiently well to, or who have lost their response to a TNFi.

Deutsche Bank analysts expect peak sales to hit $1.06B in 2020, with sales split 80:20 between UC and CD. This reflects the considerably more persuasive efficacy of vedolizumab in UC

Further analysis will be provided in our next issue of UpdatesPlus-IBD

[Product label; Product website]


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