Zealand Pharma, a Danish biotechnology company, has announced that its experimental diabetes treatment, glepaglutide, has not received FDA approval. Despite previously submitting a New Drug Application (NDA) to the US Food and Drug Administration (FDA), the company received a Complete Response Letter (CRL) stating that the agency cannot approve the drug at this time.
The CRL cites concerns related to the risk of increased fracture risk and pancreatitis associated with glepaglutide. Zealand Pharma has been working to address these issues, but the FDA has requested additional clinical trials to further assess the safety and efficacy of the treatment.
Glepaglutide is a GLP-1 receptor agonist being developed to treat type 2 diabetes. Zealand Pharma has been in talks with the FDA to determine the best course of action to move forward. The company is considering options for additional trials, as well as discussions with the FDA to clarify the required steps to secure approval.
This setback is a significant blow to Zealand Pharma, as glepaglutide was seen as a promising treatment option for type 2 diabetes patients. The company’s shares have taken a hit, and investors are awaiting further updates on the company’s plans moving forward.