Correvio Pharma has resubmitted the New Drug Application (NDA) for Brinavess (vernakalant hydrochloride) to the Food and Drug Administration (FDA) seeking approval as a treatment for the rapid conversion of adult patients with recent onset atrial fibrillation.
Brinavess is an intravenously-administered antiarrhythmic drug that prolongs atrial refractoriness and slows impulse conduction in a rate-dependent fashion. In 2006, the Company filed an NDA with the FDA for Brinavess however, the Agency responded with a refuse to file (RTF) letter. In 2017, the Agency rebuked a possible NDA resubmission, stating that the Company’s data package was not sufficient to support the resubmission.
Brinavess is approved in Europe, Canada, and several other countries. This latest submission to the FDA is supported by data from SPECTRUM, a post-approval safety study that was conducted in Europe. A total of 1778 patients were included across a total of 2009 treatment episodes following administration of Brinavess. Data from the study showed that Brinavess successfully converted 70.2% of patients into normal sinus rhythm (median time to conversion of 11 minutes).
With regard to safety, no deaths were reported in the trial; 0.8% of the patient population experienced a health outcome of interest (ie, significant hypotension, ventricular arrhythmia, atrial flutter or bradycardia). The Company also included data from nine phase 3 and phase 2 trials that were conducted over the last 8 years.
“We greatly appreciate the FDA’s willingness to work with us during the resubmission process, “ said Mark H.N. Corrigan, MD, CEO of Correvio (previously Cardiome). “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.”
For more information visit correvio.com.