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Correvio Pharma Corp
Symbol CORV
Shares Issued 34,959,880
Close 2018-10-23 C$ 5.09
Market Cap C$ 177,945,789
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Correvio to resubmit Brinavess NDA in Q2 2019

2018-10-23 07:50 ET - News Release

Dr. William Hunter reports

CORREVIO ANNOUNCES INTENTION TO RE-FILE BRINAVESS NDA IN SECOND QUARTER 2019

Based on productive pre-NDA (new drug application) discussions with the U.S. Food and Drug Administration, Correvio Pharma Corp. plans to resubmit the Brinavess (vernakalant hydrochloride, IV) new drug application during the second quarter of 2019. Brinavess is Correvio's antiarrhythmic drug for the rapid conversion of recent onset atrial fibrillation (AF). The FDA agreed that no additional studies would be required for the resubmission of the NDA.

"These communications, including our recent pre-NDA meeting, represent a significant milestone for Correvio, since we have learned from the FDA that it would be permissible to resubmit the NDA with the clinical and postmarketing surveillance data that we have already collected," said Dr. William Hunter, MD, chief executive officer and president of Correvio. "We are pleased with the collaborative nature of the FDA discussions that clarified a path forward for resubmission of the Brinavess NDA in the second quarter of 2019, and we look forward to working closely with the FDA during the review process."

Brinavess has active marketing authorization in 40 countries outside the United States and has accumulated eight years of postmarketing data.

About atrial fibrillation

Atrial fibrillation (also known as AFib or AF) is a supraventricular tachyarrhythmia with unco-ordinated 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 United States 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) (4). 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 anti-arrhythmic 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: for non-surgery patients: atrial fibrillation/u greater than seven days duration; and for postcardiac surgery patients: atrial fibrillation/u greater than days duration. Vernakalant IV is not approved for use in the United States.

About Correvio Pharma Corp.

Correvio Pharma is a revenue-generating, 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, and Esmocard and Esmocard Lyo (esmolol hydrochloride), a short-acting betablocker used to control rapid heart rate in a number of cardiovascular indications.

References

(1) C.T. January et al.; 2014 AHA/ACC/HRS guideline for the management of patients with atrial fibrillation. J. A.M. Coll Cardiol. 2014;34:e1-e76;

(2) D. Mozaffarian et al. Heart Disease and Stroke Statistics-2016 Update: A Report From the American Heart Association. Circulation. Jan. 26, 2016; 133(4):e38-60;

(3) S. Zhang et al. Atrial fibrillation in mainland China: epidemiology and current management. BMJ Heart. 2009;95:1052-1055. doi:10.1136/hrt.2008.146589;

(4) A.J. Camm 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.

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