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Zealand Pharma Reports CHMP Positive Opinion for Zeydovio (Glepaglutide) for Short Bowel Syndrome (SBS)

Shots:

  • The CHMP has recommended Zeydovio (glepaglutide) for the treatment of adults with SBS. Zealand is pursuing partnerships for the future global commercialization of Zeydovio for SBS
  • Opinion was based on the P-III (EASE-1) trial of Zeydovio (10mg, QW or Q2W) vs PBO in 106 SBS pts with intestinal failure (IF), dependent on parenteral support (PS) for ≥3 days/wk., & was further backed by interim data from EASE-2 & EASE-3 trials, LTE trials of ~2yrs. & mechanistic EASE-4 trial 
  • Zeydovio (Q2W) reduced PS requirements vs PBO in SBS pts with IF, with two-thirds achieving ≥20% reduction in weekly PS volume & 1 in 7 weaning off support entirely after 24wks.; EASE-2 & 3 long-term efficacy & safety data are expected in 2027

Ref: Globenewswire  |  Image: Zealand Pharma |  Press Release

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