Correvio’s atrial fibrillation drug voted down by FDA committee over safety concerns
pharmafile | December 11, 2019 | News story | Research and Development, Sales and Marketing | Correvio Pharma, FDA, atrial fibrillation, pharma
It has emerged that Correvio Pharma’s anti-arrhythmic therapy Brinavess was shot down by the FDA’s Cardiovascular and Renal Drugs Advisory Committee (CRDAC). The advisory panel voted 11-2 against recommending the drug for approval for the rapid conversion of recent onset atrial fibrillation (AF) in adult patients.
In a post-authorisation study conducted in Europe in 1,778 unique patients, Brinavess demonstrated a 70.2% success rate in converting AF patients into normal sinus rhythm, with median time to conversion recorded as 12 minutes from the start of the first infusion within that 70.2%. Serious adverse events were reported in 26 patients.
On review of these data, the committee came to the decision that the drug’s benefit/risk profile was not adequate enough to warrant its wider use.
The US regulator is under no obligation to follow the panel’s ruling, but it has historically tended to base its final decisions in line with these recommendations.
“We are disappointed with today’s outcome because we believe in the strength of the data we presented today for Brinavess,” said Dr Mark HN Corrigan, Chief Executive Officer of Correvio. “The treatment landscape is currently missing a rapid, efficacious and well tolerated option to treat patients with recent onset atrial fibrillation and we believe Brinavess has the potential to fill that unmet medical need. We remain confident in the safety and efficacy of the agent in the countries where it is approved and currently marketed.”
Matt Fellows
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