Zealand Pharma Submits an NDA for Glepaglutide to the US FDA for the Treatment of Short Bowel Syndrome (SBS)
Shots:
- The NDA submission was based on the results from the P-III (EASE-1) clinical trial evaluating the safety & efficacy of glepaglutide (10mg, SC, QW or Q2W) vs PBO in patients (n=106) with SBS with intestinal failure dependent on parenteral support (PS)
- The results depicted that the average reduction in PS from baseline was 5.13L/wk. (Q2W) & 3.13L/wk. (QW) vs 2.85L/wk. Moreover, 9 patients achieved enteral autonomy while no PBO patients discontinued PS & out of the patients receiving Q2W dosing, 14% achieved enteral autonomy
- Additionally, the submission was also supported by the results from the extension trials incl. (EASE-2), (EASE-3) & (EASE-4) which evaluates glepaglutide, a GLP-2 analog, in patients with SBS
Ref: zealand-pharma | Image: zealand-pharma
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Kritika is a content writer at PharmaShots. She is interested in covering recent innovations from the pharma & MedTech industry. She covers news related to Product approvals, clinical trial results, and updates. She can be contacted at connect@pharmashots.com.
