The Food and Drug Administration (FDA) has issued a complete response letter (CRL) to Acer Therapeutics regarding the New Drug Application (NDA) for Edsivo (celiprolol) for the treatment of vascular Ehlers-Danlos syndrome (vEDS) in patients with a confirmed type III collagen (COL3A1) mutation.
Edsivo, a β1-adrenoceptor antagonist with partial β2 agonist activity, is intended to help patients with vEDS by promoting normal collagen synthesis in the blood vessels, and by shifting the pressure load away from the vessels most prone to dissection and rupture. vEDS is considered the most severe subtype of EDS that often leads to complications, such as colonic perforation or an arterial rupture.
In the CRL, the FDA stated that the Company will need to conduct an adequate and well-controlled trial to evaluate the efficacy of Edsivo in patients with vEDS.
Edsivo previously received Orphan Drug designation by the FDA for the treatment of vEDS. The Company plans to request a meeting to discuss the FDA’s response.
“We remain committed to working closely with the FDA to fully understand its response,” said Chris Schelling, CEO and Founder of Acer. “We expect to respond to the FDA in the third quarter of this year.”