Zealand Pharma A/S announced that the US FDA has granted priority review designation for dasiglucagon for the prevention and treatment of hypoglycemia in pediatric patients 7 days of age and older with congenital hyperinsulinism (CHI) for up to 3 weeks of dosing with a Prescription Drug User Fee Act (PDUFA) date on December 30, 2023. To ensure the most efficient regulatory process, the review by the US FDA will be conducted in two parts under the same New Drug Application (NDA). Part 1 relates to dosing for up to 3 weeks, whereas Part 2 relates to use beyond 3 weeks.
The PDUFA date for Part 2 will be set following submission of additional analyses from existing datasets requested by the US FDA, which is expected before the end of the year. CGM was included as a secondary outcome measure in one of the two pivotal Phase 3 clinical trials. Three Phase 3 clinical trials The submission of the NDA was based on the results from two pivotal Phase 3 trials and interim results from an ongoing long-term extension trial.
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 both clinical trials, dasiglucagon for Subcutaneous infusion was assessed to be well tolerated. To ensure the most efficient Regulatory review process, the US FDA has recommended reviewing the NDA submission in two parts.
The US FDA has requested additional analyses on the use of CGM from existing datasets supporting the use of dasiglucagon in CHI beyond 3 weeks, which Zealand Pharma expects to submit before the end of the year; Part 2 does not represent a supplemental New Drug Application but is under the same NDA. In addition, dasiglucagon injection was approved as Zegalogue®? by the US FDA in 2021 for the treatment of severe hypoglycemia in adults and children with diabetes aged 6 years and older.
should not place undue reliance on these statements, or the scientific data presented. Such forward-looking statements are subject to risks, uncertainties and inaccurate assumptions, which may cause actual results to differ materially from expectations set forth herein and may cause any or all of such forward-looking statements to be incorrect, and which include, but but are expected before the end of the Year.