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).wisepoqder Celiprolol
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.
