FDA more receptive to Correvio's second Brinavess NDA

Almost two years after the US Food and Drug Administration (FDA) snubbed Correvio Pharma Corp’s (Nasdaq: CORP) filing for Brinavess (vernakalant hydrochloride, IV), the agency has accepted the New Drug Application (NDA).

The FDA cited insufficient data in refusing to accept the initial submission in August 2017, but has not demanded any additional studies be done on Brinavess (vernakalant hydrochloride, IV), the treatment for atrial fibrillation (AF) which has already been approved for marketing in Europe, Canada and several other countries worldwide.

In its acceptance letter, the FDA stated that it is currently planning to hold an advisory committee meeting to discuss the resubmitted NDA to market the antiarrhythmic drug for the rapid conversion of recent onset AF to sinus rhythm in adult patients.