Correvio Announces Brinavess® Spectrum Data to be Presented at the European Society of Cardiology 2019 Congress

Correvio Pharma Corp., a specialty pharmaceutical company focused on commercializing hospital drugs, announced that an abstract highlighting the results of the SPECTRUM study evaluating Brinavess^® (vernakalant hydrochloride, IV), the Company's antiarrhythmic drug for the rapid conversion of recent onset atrial fibrillation (AF), was selected for a poster presentation at the European Society of Cardiology (ESC) 2019 Congress taking place August 31 – September 4, 2019, in Paris. 

"SPECTRUM is a large, European, post-authorization safety study that provides important information on the safety, efficacy and use of Brinavess in nearly 1,800 patients in a real-world clinical setting," said Carin Heringa, MD, Correvio's Head of Medical Affairs. "We are honored that these data were selected for inclusion in this year's program, and we look forward to Professor Hartikainen's presentation."

A New Drug Application for Brinavess is currently under review by the U.S. Food and Drug Administration for the conversion of adult patients with recent onset AF. The FDA assigned a target action date of December 24, 2019 under the Prescription Drug User-Fee Act.

Details for the upcoming presentation are as follows:

Title: Efficacy and Safety of vernakalant for cardioversion of recent-onset fibrillation in real-world clinical practice: the SPECTRUM post-approval study
Presenter: Dr. Juha Hartikainen, Kuopio University Hospital, Kuopio, Finland
Date and time: Monday, September 2, 2019; 14:00-18:00
Location: Poster Area

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 between 5.6 million 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) is an antiarrhythmic drug that acts preferentially in the atria by prolonging atrial refractoriness and slowing impulse conduction in a rate-dependent fashion. Brinavess is approved for marketing in Europe, Canada, and several other countries worldwide. In Europe, it is approved for the rapid conversion of recent onset atrial fibrillation to sinus rhythm in adults: 1) for non-surgery patients: atrial fibrillation <7 days duration; and 2) for post-cardiac surgery patients: atrial fibrillation <3 days duration.

Vernakalant IV is not approved for use in the United States.

About Correvio Pharma Corp.

Correvio Pharma Corp. is a specialty pharmaceutical company focused on providing innovative, high-quality brands that meet the needs of acute care physicians and patients. With a commercial presence and distribution network covering over 60 countries worldwide, Correvio develops, acquires and commercializes brands for the in-hospital, acute care market segment. The Company's portfolio of approved and marketed brands includes: Xydalba^™ (dalbavancin hydrochloride), for the treatment of acute bacterial skin and skin structure infections (ABSSSI); Zevtera^®/Mabelio^® (ceftobiprole medocaril sodium), a cephalosporin antibiotic for the treatment of community- and hospital-acquired pneumonia (CAP, HAP); Brinavess^® (vernakalant IV) for the rapid conversion of recent onset atrial fibrillation to sinus rhythm; Aggrastat^® (tirofiban hydrochloride) for the reduction of thrombotic cardiovascular events in patients with acute coronary syndrome. Correvio's pipeline of product candidates includes Trevyent^®, a drug device combination that is designed to deliver treprostinil, the world's leading treatment for pulmonary arterial hypertension.

For more information, please visit www.correvio.com.

1. January CT, et al. 2014 AHA/ACC /HRS guideline for the management of patients with atrial fibrillation. J Am Coll Cardiol. 2014;34:e1-e76.
2. Mozaffarian D, et al. Heart Disease and Stroke Statistics-2016 Update: A Report From the American Heart Association. Circulation. 2016 Jan 26;133(4):e38-60.
3. Camm AJ, et al. Guidelines for the management of atrial fibrillation, The Task Force for the Management of Atrial Fibrillation of the European Society of Cardiology (ESC). Eur Heart J. 2010;31:2369-2429.