The Food and Drug Administration (FDA) has accepted for priority review the New Drug Application (NDA) for Edsivo (celiprolol; Acer Therapeutics) for the treatment of vascular Ehlers-Danlos syndrome (vEDS) in patients with a confirmed type III collagen (COL3A1) mutation.
Vascular EDS is the most severe subtype of Ehlers-Danlos syndrome where patients suffer from life-threatening arterial dissections and ruptures, as well as intestinal and uterine ruptures. In September 2017, the Company announced positive results from a pivotal clinical trial of celiprolol, a β1-andrenoceptor antagonist with partial β2 agonist activity, which confirmed the treatment to be effective in patients with vEDS.
Currently, there are no FDA-approved therapies for vEDS. A Prescription Drug User Fee Act (PDUFA) target date of June 25, 2019 has been set for the NDA. “We are excited about the possibility of making Edsivo available in the US for patients in the near future,” said William Andrews, MD, FACP, Chief Medical Officer of Acer.
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