Acer Therapeutics Inc. announced on Tuesday they received a CRL from the FDA regarding their NDA from celiprolol (Edsivo).
Acer Therapeutics Inc. has announced the US Food and Drug Administration (FDA) has denied the company’s New Drug Application (NDA) for celiprolol (Edsivo) for the the treatment of vascular Ehlers-Danlos syndrome (vEDS).
Acer announced, via a press release, they had received a Complete Response Letter (CRL) from the FDA and that the CRL called for an “adequate and well-controlled” trial to determine whether celiprolol reduced the risk of clinical events in patients with vEDS.
“We remain committed to working closely with the FDA to fully understand its response,” said Chris Schelling, chief executive officer and founder of Acer. “We expect to respond to the FDA in the third quarter of this year.”
The NDA submitted by Acer was based on the results of a clinical trial that involved 53 patients who received either twice daily celiprolol orally or a placebo for up to 5 years.
Investigators from the trial found that 5 of the 25 patients (20%) receiving celiprolol experienced an arterial rupture or dissection during the study period, compared to 14 of the 28 patients (50%) in the placebo group. The combined primary and secondary endpoints of intestinal or uterine rupture affected 6 (24%) celiprolol patients and 17 (61%) in the placebo group.
In the press release, officials from Acer stated they planned to request a meeting with the FDA to discuss their response. Celiprolol is currently approved for the treatment of management of mild to moderate hypertension and effort-induced angina pectoris.