A GLP-2 drug candidate from Zealand Pharma failed to garner FDA approval as the regulatory agency asked for an additional trial to confirm the medication's efficacy and safety.
The experimental therapy is glepaglutide, a glucagon-like peptide-2 analog under development to treat adults who have short bowel syndrome with intestinal failure and who require parenteral support.
A phase 3 trial found significant reductions in patients requiring parenteral support compared to the placebo arm with twice-weekly doses, Denmark-based Zealand Pharma said Dec. 19. However, the FDA requested another clinical trial for the to-be-marketed dose.
The drugmaker said it is disappointed in the decision and is working with the U.S.-based agency to obtain approval in the future. At the same time, Zealand is moving ahead with its plans to submit for approval with the European Medicines Agency in 2025.
Another pharmaceutical company based in Denmark, Novo Nordisk, manufactures the wildly popular GLP-1s Ozempic and Wegovy. GLP-1s and GLP-2s are hormones secreted from gut endocrine cells that promote nutrient absorption, and their pharmaceutical uses vary.
The GLP-1 drug class includes therapies approved for Type 2 diabetes, chronic weight management, cardiovascular disease and obstructive sleep apnea.
There is only one GLP-2 medication approved in the U.S.: Takeda Pharmaceuticals' Gattex (teduglutide), an injectable approved in 2012 for patients who have short bowel syndrome and are dependent on parenteral support.