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FDA Gives Thumbs Down To Correvio's Atrial Fibrillation Drug

Shanthi Rexaline

Shares of Canadian specialty pharma Correvio Pharma Corp (NASDAQ: CORV) are retreating in reaction to an adverse FDA verdict.

FDA Goes With Panel Verdict In Rejecting Brinavess

Correvio said it has received a complete response letter, or CRL, from the FDA for its NDA for Brinavess, or vernakalant IV. The decision was along the expected lines.

FDA's Cardiovascular and Renal Drugs Advisory Committee, which met Dec. 10, ruled that the benefit-risk profile of Brinavess wasn't adequate to support approval.

Brinavess is anti-arrhythmic drug that has been approved in several countries outside of the U.S. for the treatment of atrial defibrillation.

Correvio said the FDA determined the NDA cannot be approved in the present form and also provided guidance for resubmission.

Specifically, the FDA had taken exception to the drug's safety profile. The regulatory agency deemed that the company should develop an approach to select patients at low risk of cardiovascular reactions. It also sought data from an additional study to assess Brinavess' cardiovascular risk in the selected population.

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Way Forward

Correvio said it will now request a meeting with the FDA at the earliest to discuss the design and specifics of a potential study to address the concerns.

Following the negative FDA panel verdict in early December, Correvio has decided to explore strategic options, including acquisition, merger, business combination or other strategic transaction involving the company or its assets, in a bid to maximize shareholder value.

Correvio shares, which entered penny stock territory in the aftermath of the Dec. 10 Adcom verdict, have not recovered since then.

Although shares jumped 14.57% on Monday in the run up to the FDA decision, the stock was slipping 7.23% to 37 cents Tuesday morning.


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