The FDA rejects celiprolol - how should we interpret the news?

Updated: Feb 28, 2020

On Tuesday, June 25th, the U.S. Food and Drug Administration ("FDA") responded to the New Drug Application that Acer Therapeutics submitted to bring celiprolol (under the brand name Edsivo) to the U.S. as a treatment for vascular Ehlers-Danlos Syndrome ("vEDS"). In the response, the FDA declined the application, requesting a new trial to demonstrate the impact of celiprolol in vEDS.