European Approval Nears for Essential Diabetes Treatment Dasiglucagon

Introduction to Dasiglucagon

Zealand Pharma, a company known for its development of peptide-based medicines, has announced a significant milestone. They received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) regarding their dasiglucagon solution for injection. This marks a crucial step towards obtaining marketing authorization for the treatment of severe hypoglycemia in diabetes patients aged six and above.

What is Hypoglycemia?

Hypoglycemia occurs when blood sugar levels drop too low, which can be particularly dangerous for individuals with diabetes. Symptoms can include confusion, sweating, shaking, and in severe cases, loss of consciousness. Immediate treatment is essential to restore normal blood sugar levels.

Dasiglucagon is designed as a rescue treatment for these critical moments. With rapid action, it helps to quickly elevate blood sugar levels, providing a potentially life-saving option for both children and adults.

CHMP's Positive Opinion

The CHMP's endorsement is a significant achievement for Zealand Pharma. This recommendation will now be forwarded to the European Commission (EC), which will make the final decision on whether to grant marketing authorization within the European Union (EU). The decision is expected within approximately three months.

Adam Steensberg, CEO of Zealand Pharma, expressed his satisfaction with this development, highlighting the potential to reach more patients worldwide through their partnership with Novo Nordisk, a globally recognized leader in diabetes care.

FDA Approval and Clinical Trials

Dasiglucagon, under the brand name Zegalogue®, received approval from the U.S. Food and Drug Administration (FDA) in March 2021. The authorization was based on three pivotal trials involving both adults and pediatric patients with diabetes. These trials showed that dasiglucagon could restore normal blood glucose levels within a median time of 10 minutes.

Common Side Effects

The clinical trials reported some common side effects, including nausea, vomiting, headache, diarrhea, and injection site pain. However, the overall benefits of dasiglucagon in emergency settings were found to be substantial, outweighing these potential adverse effects.

Global Collaboration with Novo Nordisk

In September 2022, Zealand Pharma formed a global partnership with Novo Nordisk to commercialize Zegalogue®. This collaboration includes development, regulatory, manufacturing, and sales milestones, as well as royalties on worldwide net sales.

Future Prospects

Zealand Pharma retains the rights to other dasiglucagon development programs while focusing on further approvals and expanding the availability of this crucial medication. Their innovative approach has positioned them at the forefront of developing life-saving treatments for severe hypoglycemia.

About Zealand Pharma

Founded in 1998, Zealand Pharma is headquartered in Copenhagen, Denmark, with a U.S. presence. The company has developed over 10 drug candidates, two of which have reached the market. They maintain partnerships with several pharmaceutical companies, strengthening their market presence and innovation capabilities.

Forward-Looking Statements

Zealand Pharma's announcement includes forward-looking statements predicting future events related to the research, development, and commercialization of their products. As with all projections, these statements come with risks and uncertainties. The company cautions investors not to place undue reliance on these expectations.

Conclusion

The positive CHMP opinion for dasiglucagon is a promising development in the treatment of severe hypoglycemia. Pending final approval by the European Commission, this medication could soon benefit numerous patients across Europe, highlighting the important advancements in diabetic care made by Zealand Pharma and its partners.