Dasiglucagon lowers IV glucose needed for infants with conge
Congenital hyperinsulinism is a serious ultra-rare condition with a significant unmet medical need, which places a tremendous burden on both patients and families. We believe the outcome of this trial supports the potential of dasiglucagon as a novel treatment for those living with congenital hyperinsulinism.

In the first phase 3 trial, children aged 3 months to 12 years with more than three hypoglycemic events per week despite previous near-total pancreatectomy, or maximum medical therapy, were randomly assigned to dasiglucagon along with standard of care, or standard of care alone. The dasiglucagon group had a 40% to 50% reduction in hypoglycemia compared with standard of care when measured by masked continuous glucose monitoring.

The safety profile in the infant cohort was similar to what was observed in the first phase 3 trial. Of the 44 total participants enrolled in all of the phase 3 clinical programs, 42 continued into the ongoing safety extension trial.

In 2017, the FDA granted orphan drug designation to dasiglucagon for the treatment of congenital hyperinsulinism in children.

Source: https://www.healio.com/news/endocrinology/20220524/dasiglucagon-lowers-iv-glucose-needed-for-infants-with-congenital-hyperinsulinism