Is This Atrial Fibrillation Drug Done For After FDA Vote?

Health and Healthcare

Published: December 11, 2019 12:20 pm

Correvio Pharma Corp. (NASDAQ: CORV) shares were crushed after the firm announced the U.S. Food and Drug Administration (FDA) Cardiovascular and Renal Drugs Advisory Committee (CRDAC) decision for its New Drug Application (NDA) seeking approval for Brinavess. This ultimately could result in a sale of the company.

Unfortunately, the committee jointly voted that the benefit-risk profile was not adequate to support approval (Vote: 2 yes to 11 no).

While the FDA is not required to follow the committee’s vote, the agency considers the committee’s recommendations when making its decision. Correvio’s NDA seeking approval for Brinavess is under review by the FDA with a target action date of December 24, 2019, under the Prescription Drug User-Fee Act (PDUFA).

Brinavess is Correvio’s anti-arrhythmic drug that is currently under review by the FDA for the rapid conversion of recent onset atrial fibrillation (AF) in adult patients.

Some quick background: AF is a common cardiac rhythm disturbance that increases in prevalence with advancing age. According to the American Heart Association, estimates of the prevalence of AF in the U.S. ranged from 2.7 million to 6.1 million in 2010, and is expected to rise to 12 million in 2030.

Mark H.N. Corrigan, MD, CEO of Correvio, commented on a potential sale:

Given yesterday’s FDA’s Cardiovascular and Renal Drugs Advisory Committee (CRDAC) meeting outcome for Brinavess (vernakalant IV) for the conversion of atrial fibrillation (AF), we believe it is in the best interest of our stakeholders to expand our internal corporate development efforts and formally evaluate strategic alternatives for the company.

Shares of Correvio were last seen down about 66% at $0.48, in a 52-week range of $0.43 to $4.44. The consensus price target is $4.74.

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