NASDAQ: CORV TSX: CORV
Correvio to schedule a Pre-NDA meeting to
discuss the content and format of a potential resubmission of the
NDA
VANCOUVER, June 11, 2018
/PRNewswire/ - Correvio Pharma Corp. (NASDAQ: CORV) (TSX: CORV), a
revenue-generating, specialty pharmaceutical company focused on
providing innovative, high-quality brands that meet the needs of
acute care physicians and patients, today announced that it has
received a response from the U.S. Food and Drug Administration
(FDA) regarding the regulatory path forward in the US for
BRINAVESS® (vernakalant hydrochloride, IV), Correvio's
antiarrhythmic drug for the rapid conversion of recent onset atrial
fibrillation (AF). In its written reply, the FDA informed
Correvio that it would be permissible to resubmit the BRINAVESS New
Drug Application (NDA) and agreed that the Company may schedule a
Pre-NDA meeting. Correvio currently expects that the Pre-NDA
meeting with the FDA will take place in the fourth quarter of
2018.
"In our most recent communication with the FDA, we asked the
Agency if the Division of Cardiovascular and Renal Products would
be willing to meet to discuss a regulatory path forward for
Brinavess," said William Hunter, MD,
CEO and President of Correvio. "We are pleased that the Agency has
agreed to discuss Brinavess in a pre-NDA meeting, which we will
seek to have in the fourth quarter."
While there can be no assurance that the Company can address all
matters that the FDA may consider relevant, in its communication,
the Agency noted that Correvio, "consider collecting data from
electronic health records or administrative claims from health
systems in countries where vernakalant is marketed as a source of
additional data that could be informative to the FDA's evaluation
of the NDA resubmission." BRINAVESS® has received
marketing authorizations in 42 countries outside the US and
accumulated eight years of post-marketing data, in addition to
completing SPECTRUM, a 2,000-patient prospective,
post-authorization safety study in the European Union.
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.
References
- 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.
- 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.
- Kirchhof P et al. 2016 ESC Guidelines for the management of
atrial fibrillation developed in collaboration with EACTS European
Heart Journal (2016) 37, 2893–2962.
About Correvio Pharma Corp.
Correvio Pharma Corp. 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.
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.
Correvio is traded on the NASDAQ Capital Market (CORV) and the
Toronto Stock Exchange (CORV). For more information, please visit
our web site www.correvio.com.
Forward-Looking Statement Disclaimer
Certain statements in this news release contain forward-looking
statements within the meaning of the U.S. Private Securities
Litigation Reform Act of 1995 or forward-looking information under
applicable Canadian securities legislation ("forward-looking
statements") that may not be based on historical fact, including
without limitation statements containing the words "believe",
"may", "plan", "will", "estimate", "continue", "anticipate",
"intend", "expect" and similar expressions. These forward-looking
statements include, but are not limited to, possible future
meetings with the FDA, including the risks associated with
regulatory reviews, as well as any possible regulatory path forward
with respect to BRINAVESS®. Such forward-looking
statements involve known and unknown risks, uncertainties and other
factors that may cause the actual results, events or developments
to be materially different from any future results, events or
developments expressed or implied by such forward-looking
statements. A discussion of the risks and uncertainties
facing Correvio are discussed in the most recent annual and
quarterly reports of our former parent company Cardiome Pharma
Corp., and detailed from time to time in our other filings with the
Securities and Exchange Commission ("SEC") available at www.sec.gov
and the Canadian securities regulatory authorities at
www.sedar.com. In particular, we direct your attention to the risks
titled "Clinical trials for our product candidates are expensive
and time consuming, and their outcome is uncertain" and "The
results of pre-clinical studies and initial clinical trials are not
necessarily predictive of future results, and our current product
candidates may not have favorable results in later trials or in the
commercial setting" in Correvio's Annual Report on Form 20-F for
the year ended December 31,
2018. All of the risks and certainties disclosed in these
filings are hereby incorporated by reference in their entirety.
While Correvio makes these forward-looking statements in good
faith, given these risks, uncertainties and factors, you are
cautioned not to place undue reliance on any forward-looking
statements made in this press release. All forward-looking
statements made herein are based on our current expectations and we
undertake no obligation to revise or update such forward-looking
statements to reflect subsequent events or circumstances, except as
required by law.
Correvio® and the Correvio Logo are the proprietary
trademarks of Correvio Pharma Corp.
Aggrastat® and Brinavess® are trademarks
owned by Correvio and its affiliates worldwide.
Xydalba™ is a trademark of Allergan Pharmaceuticals International
Limited, and used under license.
Zevtera® and Mabelio® are trademarks owned by
Basilea Pharmaceutica International Ltd., and used under
license.
Esmocard® and Esmocard Lyo® are trademarks
owned by Orpha-Devel Handels und Vertriebs GmbH, and used under
license.
Trevyent® is a trademark of SteadyMed and used under
license.
All other trademarks are the property of their respective
owners.
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SOURCE Correvio Pharma Corp.