Trial Profile
A Randomized Trial in 2 Parts: Double-Blind, Placebo-Controlled, Crossover Part 1 and Open-label Part 2, Evaluating the Efficacy and Safety of Dasiglucagon for the Treatment of Children with Congenital Hyperinsulinism
Status:
Completed
Phase of Trial:
Phase II/III
Latest Information Update: 04 Mar 2024
Price :
$35
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At a glance
- Drugs Dasiglucagon (Primary)
- Indications Congenital hyperinsulinism
- Focus Registrational; Therapeutic Use
- Sponsors Zealand Pharma
- 27 Feb 2024 According to a Zealand Pharma media release, in the first half of 2024, to support use of dasiglucagon beyond three weeks, the company plans to submit additional analyses, requested by the FDA, from existing continuous glucose monitoring (CGM) datasets that were included as a secondary outcome measure in the Phase 3 program.
- 27 Feb 2024 According to a Zealand Pharma media release, company expects to resubmit the New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for prevention & treatment of hypoglycemia in pediatric patients with CHI for up to three weeks of dosing in the first half of 2024. The resubmission is in response to a Complete Response Letter issued by the FDA in Dec 2023 related to deficiencies identified at a third-party manufacturing facility that are not specific to dasiglucagon.
- 30 Aug 2023 According to a Zealand Pharma media release, to ensure the most efficient regulatory process, the review by the US FDA will be conducted in two parts under 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.