- (PLX AI) - Zealand Pharma Announces Positive Results from Phase 3 Trial of Dasiglucagon in Pediatric Patients with Congenital Hyperinsulinism (CHI)
- • Zealand Pharma says Dasiglucagon met the primary endpoint with statistical significance - reducing the requirement for intravenous glucose by 55% compared to placebo in this pediatric patient population (ages 7 days to 12 months) when compared to placebo
- • Dasiglucagon treatment was assessed as well-tolerated in this study and 11 out of 12 patients are continuing into the long-term safety extension study
- • These data, together with data from a previously reported Phase 3 study in older children with CHI, are expected to form the basis of a new drug application (NDA) for dasiglucagon treatment in the management of CHI, with the U.S. Food and Drug Administration
- • Submission is anticipated by end of 2022
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