Posted by Michael Wonder on 26 Jun 2019
Acer Therapeutics receives complete response letter from U.S. FDA for use of Edsivo (celiprolol) in vEDS patients
25 June 2019 - Acer Therapeutics today announced it has received a complete response letter from the U.S. FDA regarding its new drug application for Edsivo for the treatment of vascular Ehlers-Danlos syndrome.
The letter states that it will be necessary to conduct an adequate and well-controlled trial to determine whether celiprolol reduces the risk of clinical events in patients with vascular Ehlers-Danlos syndrome.
Acer plans to request a meeting to discuss the FDA’s response.
