Skip to NavigationSkip to content

Correvio's atrial fibrillation drug voted down by FDA committee over safety concerns

Published on 11/12/19 at 12:00pm

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

Mission Statement
Pharmafile.com is a leading portal for the pharmaceutical industry, providing industry professionals with pharma news, pharma events, pharma service company listings and pharma jobs,
Site content is produced by our editorial team exclusively for Pharmafile.com and our industry newspaper Pharmafocus. Service company profiles and listings are taken from our pharmaceutical industry directory, Pharmafile, and presented in a unique Find and Compare format to ensure the most relevant matches