Cardiome provides U.S. regulatory update for Brinavess.
Cardiome Pharma Corp. announced Monday that it has received a response from the U.S. Food and Drug Administration (FDA) regarding the regulatory path for Brinavess (vernakalant hydrochloride, IV), the company’s antiarrhythmic drug for the rapid conversion of recent onset atrial fibrillation (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 (NDA).
“In our most recent communication with the FDA, we proposed resubmission of the NDA based upon the original file and six years of accumulated safety data from sales of Brinavess in thirty-three countries, augmented by interim results from over 1,100 patients enrolled in the SPECTRUM study, a prospective post-authorization European Union safety study, along with pre-clinical data from subsequent studies the company completed at the FDA’s request,” said William Hunter, M.D., CEO and president of Cardiome.
“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,” Hunter added. “We will continue to have a dialogue with the FDA as we review our regulatory options.”
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.
Brinavess (vernakalant HCl, IV) is an antiarrhythmic drug that acts preferentially in the atria by prolonging atrial refractoriness and slowing impulse conduction in a rate-dependent fashion. It is approved for marketing in Europe, Canada, and several other countries worldwide. In Europe, it is approved for the rapid conversion of recent onset atrial fibrillation to sinus rhythm in adults: 1) for non-surgery patients: atrial fibrillation < 7 days duration; and 2) for post-cardiac surgery patients: atrial fibrillation < 3 days duration.
Vernakalant IV is not approved for use in the United States.
(Source: PR Newswire)