Acer Therapeutics Submits NDA for EDSIVO for the Treatment of vEDS

Acer Therapeutics (Nasdaq:ACER), a pharmaceutical company focused on the acquisition, development and commercialization of therapies for serious rare and ultra-rare diseases with critical unmet medical need, today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for EDSIVO^™ for the treatment of vascular Ehlers-Danlos syndrome (vEDS).

As quoted in the press release:

Pursuant to the Prescription Drug User Fee Act (PDUFA), the FDA has 60 days to determine whether to accept the submission for review. Along with the NDA submission, Acer has requested Priority Review, which if granted, could result in a six-month review period. Priority Review is a designation given to drugs that offer a significant improvement in treatment or provide treatment where no satisfactory alternative therapy exists.

“Our NDA submission represents the culmination of extensive efforts of our employees, investigators, clinical trial sites, contract research organizations, caregivers and patients,” said William Andrews, M.D., FACP, Chief Medical Officer of Acer. “We now look forward to continuing to work with the FDA as they review our NDA, with hopes to make EDSIVO^™ available as quickly as possible in the U.S. We are grateful to the vEDS patient and advocacy community for their continued involvement, support and feedback as we work together to advance EDSIVO^™, which has the potential to be a significant step forward in the care of patients with this devastating disease.”

Click here to read the full press release.