Correvio Pharma Corp. (NASDAQ: CORV) (TSX: CORV), a specialty pharmaceutical company focused on commercializing hospital drugs, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the resubmitted New Drug Application (NDA) for Brinavess™ (vernakalant hydrochloride, IV), an antiarrhythmic drug for the rapid conversion of recent onset atrial fibrillation (AF) to sinus rhythm in adult patients. The FDA assigned a target action date of December 24, 2019 under the Prescription Drug User-Fee Act (PDUFA). In its acceptance letter, the FDA stated that it is currently planning to hold an advisory committee meeting to discuss this application.
“The FDA’s acceptance of this resubmitted NDA marks another important milestone for Correvio and for the global Brinavess program,” said Mark H.N. Corrigan, MD, CEO of Correvio. “As a potential new AF treatment, with a well-characterized efficacy and safety profile, we believe that Brinavess, if approved, will be an attractive addition to the AF treatment landscape. We look forward to working with the FDA during the review process.”
The Company also announced certain preliminary financial results for the second quarter ended June 30, 2019. Revenue for the second quarter is expected to be in the range of $7.2 to 7.6 million (USD), which represents an approximately 20% increase compared to the second quarter of 2018, despite 5% weakness in the Euro. As of June 30, 2019, Correvio had cash, cash equivalents and unrestricted cash totalling approximately $12.9 million (USD). The Company will report its full financial results in August.