Zealand Pharma has submitted a new drug application (NDA) to the US Food and Drug Administration (FDA) for its treatment dasiglucagon for use in paediatric patients aged seven days or older with congenital hyperinsulinism (CHI).

Based on an announcement released on 30 June, the application is based on clinical data from two Phase III studies and interim results from an ongoing long-term extension trial (NCT03941236). This includes results from a Phase III trial (NCT041724412), which tested dasiglucagon’s efficacy and safety in a hospital setting among 12 neonates and infants with CHI aged seven days to 12 months.

In the first part of the trial, which took the form of a 48-hour crossover study, dasiglucagon reduced the need for glucose infusions by 55%.

The application also features data from a second Phase III study (NCT03777176), which tested subcutaneous dasiglucagon infusions in 32 children with CHI aged three months to 12 years. There, the use of dasiglucagon with standard of care did not significantly reduce the rate of hypoglycemia when compared to standard of care alone when assessed by intermittent self-measured plasma glucose, thus missing the trial’s primary endpoint, based on a December 2020 press release.

Marketed under the name Zegalogue for the treatment of severe hypoglycaemia in diabetic adults and children aged six years and older, dasiglucagon is a glucagon analogue that is designed to allow continuous subcutaneous infusion using a pump, per the company’s June 2023 corporate presentation. The FDA approved the drug for use in severe hypoglycaemia in March 2021. In June 2023, the company submitted a marketing authorisation application for use in the same patient population to the European Medicines Agency (EMA).

CHI is a rare genetic disease that mostly affects infants and children whose pancreatic beta cells secrete too much insulin, which results in frequent hypoglycaemia episodes. Hypoglycaemia is a state where one’s blood sugar levels are below the standard range.

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In September 2022, Zealand announced a global licence and development agreement with Novo Nordisk for the commercialisation of dasiglucagon. As part of the agreement, Zealand will be responsible for some planned regulatory, development and manufacturing activities that will support approval outside of the US, based on the September 2022 announcement.

The company received an upfront payment of DKr25m ($3.66m per the current rate), with eligibility to earn up to DKr45m ($6.6m per the current rate) in near-term development.

However, the company also faced past challenges prior to this announcement. In March 2022, Zealand announced that its then-CEO will be replaced alongside further restructuring. This included a 90% reduction of the company’s US-based workforce.

According to GlobalData’s Pharma Intelligence Centre, a consensus forecasts dasiglucagon to have global sales of $37m in 2029.