After Novartis’ near $10 billion buyout of The Medicines Company, and with it the biotech’s leading heart drug hopeful, many thought cardiovascular therapies were hot again.
But the FDA has reminded us why this can be a tricky proposition: In an AdComm this week, Correvio Pharma was hit by an overwhelmingly negative vote (11-2 against) for its drug to correct irregular rhythm in the upper chambers of the heart in adult patients.
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The FDA doesn’t have to follow the AdComm advice, but typically a negative AdComm means a negative FDA opinion, so this dents Correvio’s attempt to market its potential big moneymaker.
The drug, known as Brinavess—which is approved outside the U.S. but needs U.S. sales to boost its share, which could swell to $150 million from the American market—was voted down over serious safety risks including low blood pressure and irregular rhythm in the lower heart chambers along with deaths during the trials.
“It clearly has benefit but it does have risk,” said panel member Dr. Barry Davis of the University of Texas School of Public Health, as quoted by Reuters. “If this were the only drug or treatment around, yes, but there are other options.”
This includes older and newer blood thinners, which can help against atrial fibrillation, a condition that can up the risk of strokes and other CV events.
The drug has a record, as it tried and failed to gain FDA approval over the past 13 years and has also seen the regulator put the drug on a clinical hold.
Shares in the small biotech were more than halved premarket on the Nasdaq this morning on the news.
As part of this setback, the company said today that it would “explore strategic options to maximize stakeholder value.”
These could be an “acquisition, merger, business combination or other strategic transaction involving the company or its assets”, the biotech said.
"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," explained Mark H.N. Corrigan, M.D., chief of Correvio.
"We have a strong and growing commercial portfolio of assets being sold across the globe and we will immediately begin preparations for a potential strategic transaction while we await the U.S. Food and Drug Administration (FDA)'s decision regarding Brinavess. We are also taking steps to reduce operating costs outside the core European commercial business and a transaction committee has been formed within the Board of Directors."
The agency is set to make a final decision on the drug Christmas Eve; the biotech will be hoping for a good present, but may be facing a lump of coal.