The FDA has declined to approve Zealand Pharma’s glepaglutide, a potential competitor to Takeda’s Gattex, for the treatment of short bowel syndrome (SBS), citing insufficient evidence to support the application.
In a complete response letter (CRL), the FDA recommended that Zealand Pharma conduct an additional clinical trial to provide further data on the efficacy and safety of glepaglutide, according to a Dec. 19 statement from the Danish biotech company.
Zealand Pharma plans to continue discussions with the FDA to outline a path toward U.S. approval. The company announced it will launch a new phase 3 trial next year to address the FDA’s requirements. This trial will aim to strengthen the case for a future resubmission while also supporting regulatory applications in other regions.
Despite the setback in the U.S., Zealand Pharma will proceed with its plans to submit a marketing authorization application to European regulators in 2025.
Glepaglutide is a long-acting GLP-2 analog designed as a liquid formulation administered via an autoinjector. The drug aims to reduce or eliminate intravenous dependency for SBS patients with intestinal failure.
The FDA submission was based on data from the phase 3 EASE-1 trial, a placebo-controlled study. The trial met its primary endpoint, demonstrating that twice-weekly doses of glepaglutide significantly reduced weekly parenteral support volume by 5.13 liters at 24 weeks compared to baseline. However, once-weekly doses did not achieve statistically significant results. Zealand Pharma did not clarify which dosing regimen was used in the FDA submission.
“We remain firm in our belief that glepaglutide represents a significant advance in GLP-2-based therapies for SBS patients dependent on parenteral support,” said David Kendall, M.D., Chief Medical Officer of Zealand Pharma. “We are committed to working closely with the FDA to establish a path to regulatory approval so that we can bring glepaglutide to patients in the U.S.”
Zealand Pharma continues to position glepaglutide as a promising option for SBS patients, despite the regulatory hurdle.
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