Welcome to the Zealand Pharma Update!
Company Announcement No. 48 / 2024
Zealand Pharma has just provided a U.S. regulatory update on dasiglucagon in congenital hyperinsulinism. The U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for dasiglucagon in CHI for up to three weeks of dosing due to the timing of a third-party manufacturing facility reinspection.
What does this mean?
The reinspection of the facility was completed in August/September 2024, and a new inspection classification is currently pending. Despite this setback, Zealand remains committed to working with the FDA and the third-party manufacturer to bring dasiglucagon to patients in the U.S. as soon as possible.
This news comes from Copenhagen, Denmark, as of October 9, 2024 – Zealand Pharma A/S (Nasdaq: ZEAL) (CVR-no. ).
While this delay may be disappointing, it is important to remember that the ultimate goal is to provide a safe and effective treatment for patients with congenital hyperinsulinism. Zealand Pharma is dedicated to ensuring that dasiglucagon meets all necessary requirements before it is made available to the public.
Zealand Pharma’s commitment to transparency and cooperation with regulatory agencies is a testament to their dedication to patient safety and well-being. We look forward to seeing the positive impact that dasiglucagon will have on those affected by CHI once it receives approval.
How will this affect me?
As a patient with congenital hyperinsulinism in the U.S., this delay may be frustrating, but it is important to remember that Zealand Pharma is working diligently to bring dasiglucagon to market as quickly as possible. In the meantime, it is essential to work closely with your healthcare provider to manage your condition effectively.
How will this affect the world?
The delay in the approval of dasiglucagon for CHI in the U.S. may have a ripple effect on the global healthcare community. Other countries and regulatory agencies may take additional precautions before approving the drug for their own markets, potentially delaying access for patients worldwide. However, Zealand Pharma’s commitment to meeting regulatory standards and ensuring patient safety is a positive sign for the future of healthcare advancements.
Conclusion
While the U.S. regulatory update on dasiglucagon in congenital hyperinsulinism may be a temporary setback, Zealand Pharma’s dedication to patient safety and well-being is unwavering. We remain hopeful that dasiglucagon will soon be available to those in need, providing a much-needed treatment option for individuals with CHI. Stay tuned for further updates on this important development in the world of healthcare.
