Submission of NDA to the FDA of dasiglucagon for the prevention and treatment of hypoglycemia in pediatric patients.- Zealand Pharma A/S

“CHI is a serious and debilitating condition associated with recurrent episodes of dangerously low blood sugar levels which, if left untreated, can result in serious complications, including a risk of brain damage. The management of CHI also carries a significant medical, psychosocial and financial burden for the affected children and their families, including the need for frequent feeding and monitoring of blood glucose levels”, said David Kendall, MD, Chief Medical Officer of Zealand Pharma. “We believe dasiglucagon, if approved, can help address a significant unmet medical need for infants and children with CHI, and we are pleased to submit this treatment for regulatory review and potential approval in the US.”

Three Phase III clinical trials : The submission is based on the results from two pivotal Phase III trials and interim results from an ongoing long-term extension trial. i. One trial (NCT04172441) evaluated the efficacy and safety of dasiglucagon for subcutaneous infusion in a hospital setting in 12 neonates and infants with CHI aged 7 days to 12 months. In part 1 of this trial, a double-blind placebo-controlled 48 hours crossover study, dasiglucagon reduced the need for intravenous infusion of glucose by 55% compared to placebo. In part 2 of the trial, being 21 days open-label treatment, 10 of the 12 neonates and infants weaned off intravenous glucose for at least 12 hours and 7 of the 12 neonates and infants remained weaned off intravenous glucose at the end of the trial without concomitant pancreatic surgery. ii. A second trial (NCT03777176) evaluated dasiglucagon for subcutaneous infusion in a homecare setting in 32 children with CHI aged 3 months to 12 years. Dasiglucagon treatment did not significantly reduce the number of intermittent self-measured plasma glucose (SPMG)-measured hypoglycemia events per week when compared to standard of care alone. However, when using continuous glucose monitoring (CGM), dasiglucagon treatment, when added to standard of care therapies, reduced the time in hypoglycemia, defined as glucose <70 mg dl, by approximately 50% and reduced the number of hypoglycemic events by approximately 40% compared to standard of care treatment alone. in both clinical trials, dasiglucagon for subcutaneous infusion was assessed to be well tolerated. skin reactions and gastrointestinal disturbances were the most frequently reported adverse events and 42 of the 44 participants in the two studies continued into the long-term trial (nct03941236), evaluating dasiglucagon for the treatment of infants and children with chi.></70>