Thursday, September 19, 2019

Thursday, September 19, 2019

New drug application for Brinavess submitted to FDA


A New Drug Application (NDA) was resubmitted by Correvio Pharma Corporation to the Food and Drug Administration for the approval of Brinavess.

The drug targets antiarrhythmia for the rapid conversion of adult patient with recent onset atrial fibrillation.

“The resubmission of the Brinavess NDA is a major milestone for Correvio and is the culmination of substantial effort by our employees and the investigators who have dedicated themselves toward investigating this potential new treatment option for adult patients with recent onset AF,” said Mark Corrigan, CEO of Correvio. “If approved, we believe that Brinavess will be an attractive addition to the AF treatment landscape and will provide physicians with a well-tolerated and effective pharmacologic treatment approach to cardioversion.  We greatly appreciate the FDA's willingness to work with us during the resubmission process and, assuming the refiling is accepted as a complete resubmission, we look forward to working closely with the FDA as they review the new data supporting the safety and efficacy of Brinavess.”

A SPECTRUM study in Europe evaluated 1,778 patients and concluded that treatment with Brinavess successfully converted 70.2 percent of atrial fibrillation patients and showed a medial time to conversion of 11 minutes.

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US Food and Drug Administration

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