Zealand Pharma announces positive CHMP opinion for dasiglucagon for treatment of severe hypoglycemia in diabetes from European Medicines Agency
20045078), a biotechnology company focused on the discovery and development of innovative peptide-based medicines, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending granting marketing authorization for dasiglucagon solution for injection in the treatment of severe hypoglycemia in adults, adolescents, and children aged 6 years and over with diabetes mellitus.
- 20045078), a biotechnology company focused on the discovery and development of innovative peptide-based medicines, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending granting marketing authorization for dasiglucagon solution for injection in the treatment of severe hypoglycemia in adults, adolescents, and children aged 6 years and over with diabetes mellitus.
- "We are very pleased that the European regulatory authorities have recommended approval of dasiglucagon as a rescue treatment for very low blood sugar in people with diabetes," said Adam Steensberg, Chief Executive Officer of Zealand Pharma.
- The positive opinion from the CHMP will be referred to the European Commission (EC) for a final decision whether to grant marketing authorization in the European Union (EU).
- Dasiglucagon injection was approved by the U.S. FDA in March 2021 under the brand name Zegalogue®.