Zealand Pharma Misses the Mark, FDA Rejects Glepaglutide in Latest Announcement

Zealand Pharma announced that the US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for the company’s New Drug Application (NDA) for glepaglutide, a once-weekly GLP-1 receptor agonist for the treatment of type 2 diabetes. This means that the FDA has not approved the drug at this time. The CRL typically indicates that the FDA requires additional clinical or non-clinical data to support the approval of the drug. The company did not specify the exact reasons for the CRL, but stated that it plans to work with the FDA to address the issues and resubmit the NDA. Zealand Pharma had initially filed the NDA in February 2022 and was hoping to gain FDA approval by the end of 2022. With the CRL, the company will need to re-evaluate its timeline and strategy for bringing glepaglutide to market.