Posted by Michael Wonder on 01 Jul 2023
Zealand Pharma submits new drug application to US FDA for dasiglucagon in congenital hyperinsulinism
30 June 2023 - Zealand Pharma today announced the submission of a new drug application to the US FDA for dasiglucagon for the prevention and treatment of hypoglycaemia in paediatric patients 7 days of age or older with congenital hyperinsulinism.
The submission is based on the results from two pivotal Phase 3 trials and interim results from an ongoing long-term extension trial.
