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]

Monday, May 19, 2014

Boehringer-Ingelheim takes adalimumab biosimilar into Phase 3 development for RA

  • Boehringer has announced that a global Phase 3 study of BI 695501 will  open this month
  • The study will compare BI 695501 to US-sourced Humira in 600 patients with active rheumatoid arthritis
  • Primary endpoints, DAS28 and ACR20 at 24wks are expected to read out Sept 2015
  • Secondary endpoints include all-important immunogenicity at 24wks.  The study is expected to complete May 2016 with additional 48-48wk safety and efficacy endpoints
Comments: This is the third adalimumab biosimilar to enter Phase 3.  Sandoz advanced GP2017 for psoriasis Dec 2013.   Amgen is developing ABP 501 for both RA and psoriasis.  The latter is expected to complete March 2016, while the RA study opened Oct 2013 and is due to read out April 2015, one year before the Boehringer study is set to complete.  Of note, the Boehringer study has co-primary endpoints while Amgen is reporting just ACR20 as a primary end-point.  The Boehringer study study also has 100 more patients.  The full impact of the subtleties of Boehringer's study (ie US sourced Humira; co-primary end-point; time frame and study size) will be evaluated in the context of the FDA's recent draft guidance on biosimilars in our next issues of UpdatesPlus (RA, Psoriasis and IBD)

To view a recent issue of UpdatesPlus-Rheumatoid Arthritis click here - for subscription information please contact: fiona.watts(at)leaddiscovery(dot)co(dot)uk