FDA: Cardiome's BRINAVESS Data Would Not Be Sufficient To Support Resubmission

(RTTNews) - Cardiome Pharma Corp. (CRME,COM.TO) said that it has received a response from the U.S. Food and Drug Administration regarding the regulatory path for BRINAVESS (vernakalant hydrochloride, IV), the Company's antiarrhythmic drug for the rapid conversion of recent onset atrial fibrillation or AF. In its written reply, the FDA advised Cardiome that the data package proposed by Cardiome would not be sufficient to support a resubmission of the BRINAVESS New Drug Application or NDA.

"We are disappointed that the Agency did not find these data compelling enough to recommend a resubmission, especially when several regulatory bodies in major jurisdictions around the world, including Canada in March 2017, have found the drug to be safe and effective. We will continue to have a dialogue with the FDA as we review our regulatory options,"said William Hunter, MD, CEO and President of Cardiome.

Cardiome believes the clinical trial and commercial experience with BRINAVESS demonstrates that it is a best-in-class, fast-acting, atrial fibrillation converting agent and it intends to explore every reasonable avenue available to make Vernakalant available in the United States.