Correvio Pharma Corp., a specialty pharmaceutical company focused on commercializing hospital drugs, announced that the U.S. Food and Drug Administration (FDA) Cardiovascular and Renal Drugs Advisory Committee (CRDAC) met to review the Company's New Drug Application (NDA) seeking approval for Brinavess. The Committee jointly voted that the benefit-risk profile was not adequate to support approval (Vote: 2 Yes to 11 No). Brinavess is Correvio's anti-arrhythmic drug that is currently under review by the FDA for the rapid conversion of recent onset atrial fibrillation (AF) in adult patients. While the FDA is not required to follow the committee's vote, the agency considers the committee's recommendations when making its decision. Correvio's NDA seeking approval for Brinavess is under review by the FDA with a target action date of December 24, 2019 under the Prescription Drug User-Fee Act (PDUFA).
"We are disappointed with today's outcome because we believe in the strength of the data we presented today for Brinavess," said Mark H.N. Corrigan, MD, 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."
The CRDAC is an independent panel of experts that evaluates data concerning the efficacy and safety of marketed and investigational products for use in the treatment of cardiovascular and renal diseases and makes appropriate recommendations to the FDA. Although the FDA will consider the recommendation of the panel, the final decision regarding the approval of the product is made by the FDA solely, and the recommendations by the panel are non-binding.
The Brinavess NDA is supported by data from SPECTRUM, a post-authorization safety study that was conducted in Europe which evaluated 1,778 unique patients across a total of 2,009 treatment episodes following administration of Brinavess. The SPECTRUM data demonstrated that treatment with Brinavess successfully converted 70.2% of those treated AF patients into normal sinus rhythm. In addition, treatment with Brinavess showed a median time to conversion of 12 minutes from the start of the first infusion among patients who successfully converted. The cumulative incidence of health outcomes of interest (defined as significant hypotension, ventricular arrhythmia, atrial flutter, or bradycardia) was reported in less than 1% of patients. Twenty-eight serious adverse events were reported in 26 of the 1,778 patients, with no deaths and no torsades de pointes reported in the study. In addition to SPECTRUM, the Brinavess NDA is supported by nine Phase 3 and Phase 2 clinical trials and over eight years of post-marketing experience in approximately 50,000 treatment patients worldwide. Brinavess has received marketing authorizations in 41 countries outside the U.S.
About Atrial Fibrillation
Atrial fibrillation (also known as AFib or AF) is a supraventricular tachyarrhythmia with uncoordinated atrial activation resulting in ineffective atrial contraction and if left untreated, structural and/or electrophysiological atrial tissue abnormalities.1 AF is a common cardiac rhythm disturbance that increases in prevalence with advancing age.1 According to the American Heart Association, estimates of the prevalence of AF in the U.S. ranged from 2.7 million to 6.1 million in 2010, and is expected to rise to 12 million in 2030.2
There are two strategies to manage AF, namely, rhythm- or rate-control. A rhythm-control strategy may be used in patients who are severely compromised, remain symptomatic despite adequate rate control, when adequate rate control is difficult to achieve, when long term rhythm control therapy is preferred, younger patient age, presence of tachycardia-mediated cardiomyopathy, and first episode of AF.1,3 Early intervention with a rhythm-control strategy to prevent progression of AF may be particularly beneficial to the AF patient.1
About Brinavess™
Brinavess (vernakalant HCl, IV) i...
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