Zealand Pharma gain FDA approval for Zegalogue (dasiglucagon) injection for hypoglycaemia
Zealand Pharma has received approval from the FDA for Zegalogue (dasiglucagon) injection, for the treatment of severe hypoglycaemia in people with diabetes. The approval was based on efficacy results from three randomized, double-blind, placebo-controlled multicentre Phase 3 studies of Zegalogue in children aged 6 to 17 and in adults with type 1 diabetes. Dapiglutide (pINN) is a potential first-in-class and long-acting GLP-1R/GLP-2R dual agonist designed to improve management of SBS beyond what is achievable with mono GLP-2 treatments, the company stated.
The primary endpoint was successfully achieved across the adult and paediatric studies with a significantly faster median time to blood glucose recovery of only ten minutes following Zegalogue administration compared to 30-45 minutes placebo. In the main Phase 3 adult trial 99% of patients recovered within 15 minutes. In these Phase 3 trial results the most common adverse events reported (≥2%) were nausea, vomiting, headache, diarrhoea and injection site pain in adults; and nausea, vomiting, headache and injection site pain in paediatric patients. The approval was received from the FDA four days ahead of the scheduled PDUFA date. Zealand is planning to launch Zegalogue in the US in June 2021.
Zealand Pharma announced the initiation by partner Boehringer Ingelheim of two Phase 2 trials for BI 456906. In April 2021, Zealand announced the initiation of two Phase 2 trials for the GLP-1/glucagon dual agonist for adults who are overweight or obese and for adults with non-alcoholic steatohepatitis (NASH). The compound is already being investigated in an ongoing Phase 2 study in people with type 2 diabetes mellitus. The new study is to investigate if there are additional benefits on both chronic weight management, and NASH to prevent progression to cirrhosis compared to currently available.
“The recent FDA approval of Zegalogue was a landmark achievement for Zealand. It marks our evolution from a research and development focused organization to a fully integrated biopharmaceutical company. This is a goal that we set ourselves and that we are delivering. This milestone would not have been possible without the scientists who discovered Zegalogue, the clinical and regulatory teams who advanced its development and ensured its full approval from the FDA, and the members of our growing commercial organisation who are working to bring this treatment to the patients who need it most,” said Emmanuel Dulac, President and Chief Executive Officer at Zealand Pharma. “The commercial launch of Zegalogue in late June, along with our noteworthy pipeline momentum, will position us well as we continue to work toward our vision of offering five commercialized products by 2025.”