Correvio Pharma is not having a happy holiday. After being hit by an FDA AdComm rejection a few weeks back, its heart drug has now also been denied approval by the FDA.
In the AdComm, the Canadian company saw an overwhelmingly negative vote (11-2) against its drug to correct irregular rhythm in the upper chambers of the heart in adult patients. It 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.
The drug, known as Brinavess (vernakalant IV), 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.
The drug has a long 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.
Now, with more than a touch of inevitability, the FDA has slapped a complete response letter (CRL) on the company and its ill-fated drug, saying that “it cannot approve the Brinavess NDA in its present form and provided recommendations needed for resubmission.” The biotech released this update late Christmas Eve in the hope, you would assume, of avoiding too much media and investor scrutiny.
The reasons for the CRL were safety: “The FDA indicated that Correvio will need to develop an approach to select patients who are at low risk of adverse cardiovascular reactions and that data from an additional, potentially uncontrolled, clinical study will be needed to assess Brinavess' cardiovascular risk in the selected patient population and to support an NDA resubmission,” said the biotech.
This will add yet more time and great expensive for the company. According to Correvio’s statement, the FDA also stated that the risk of serious cardiovascular adverse reactions “will need to be much less than 1% in the selected patient population.”
Correvio says it will meet up with the regulator as soon as possible but “currently believes that enrollment of both U.S. and ex-U.S. subjects may be acceptable to the Agency based on preliminary feedback.”
This all comes as it continues to “explore strategic alternatives” that could lead to the biotech, and/or its assets, being sold off.
And things are not looking brighter: The company is now deeply mired in a series of legal cases, both against it after the negative AdComm, whilst it is also pursuing a case against Eddingpharm (Asia) Macau Commercial Offshore relating to its distribution of its cardiovascular med Aggrastat “in respect of certain contractual breaches.”