FDA Issued Complete Response Letter on Brinavess Approval

| By | FDA, New Drug Application
0
112

Correvio Pharma announced that the FDA issued a complete response letter regarding its filing seeking approval of Brinavess (vernakalant) for the rapid conversion of recent-onset atrial fibrillation in adults, sending shares down as much as 12%. In early December, the company indicated that it was weighing its strategic options, including a possible sale, after an FDA advisory panel voted against recommending approval for the drug.

According to Correvio, the FDA agreed that there is “substantial evidence” of Brinavess’ effectiveness, but “the data do not provide reassuring evidence of [the drug’s] safety.” The agency had put a hold on US trials of Brinavess in 2010 after a patient treated with the therapy experienced cardiovascular (CV) collapse and died. The hold remains in place, but the FDA accepted a resubmitted filing from Correvio this past July.

Correvio noted that in the complete response letter, the FDA said the company will have to “develop an approach to select patients who are at low risk of adverse CV reactions and that data from an additional, potentially uncontrolled, clinical study will be needed to assess Brinavess’ CV risk in the selected patient population” in order to support another resubmission. The regulator also indicated that the risk of serious CV adverse reactions will need to be “much less than 1%” in this population.

Meanwhile, Correvio said it plans to discuss with the FDA the design and specifics of a potential study to address the agency’s concerns, adding that it “currently believes that enrolment of both US and ex-US subjects may be acceptable to the FDA based on preliminary feedback.”

Brinavess is cleared in 41 countries outside the US, including Canada and Europe.