Zealand Pharma gets FDA priority review in congenital hyperinsulinism


The FDA granted priority review designation for Zealand Pharma’s (NASDAQ:ZEAL; CVR-no. 20045078) dasiglucagon for the prevention and treatment of hypoglycemia in pediatric patients seven days of age and older with congenital hyperinsulinism (CHI) for up to three weeks of dosing.

Congenital hyperinsulinism is a severe, ultra-rare genetic disease, primarily affecting infants and children, in which the pancreatic beta cells dysfunction and secrete too much insulin, leading to frequent, recurrent, and often severe episodes of hypoglycemia.

The company’s regulatory review will be conducted in two parts under the same NDA. Part 1 relates to dosing of up to three weeks, while Part 2 relates to the use beyond three weeks.

Supporting the use of dasiglucagon in CHI beyond three weeks, the FDA has requested additional analyses from existing continuous glucose monitoring (CGM) datasets, which are expected to be submitted before the end of the year. CGM was included as a secondary outcome measure in one of the two pivotal Phase 3 clinical trials.

David Kendall, M.D. and CMO of Zealand, said priority review is a “strong testament to the potential value of this product to patients.”