NASDAQ: CORV TSX: CORV
VANCOUVER, Dec. 10, 2019 /PRNewswire/ - Correvio Pharma
Corp. (NASDAQ: CORV) (TSX: CORV), a specialty pharmaceutical
company focused on commercializing hospital drugs, today 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) 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.
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.
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.
- Benjamin EJ et al. Heart Disease and Stroke Statistics-2019
Update: A Report From the American Heart Association. Circulation.
2019 Mar 5;139(10):e56-e528.
- 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.
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 (collectively,
"forward-looking statements"). Forward-looking statements include
statements that may relate to our plans, objectives, goals,
strategies, future events, future revenue or performance, capital
expenditures, financing needs and other information that may not be
based on historical fact. Forward-looking statements can often be
identified by the use of terminology such as "believe", "may",
"plan", "will", "estimate", "continue", "anticipate", "intend",
"expect", "look forward to" and similar expressions.
Forward-looking statements are necessarily based on estimates and
assumptions made by us based on our experience and perception of
historical trends, current conditions and expected future
developments, as well as other factors we believe are
appropriate.
By their very nature, 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. These
forward-looking statements include, but are not limited to,
statements relating to the approval of Brinavess by the FDA and the
timing of any such approval. In particular, no statement herein
should be understood to mean: (i) that the FDA will find our
underlying clinical trial data to be acceptable; (ii) that the FDA
will find our manufacturing sites acceptable and validate them; or
(iii) that, in the event the FDA approves the Company's NDA, it
will require substantive Risk Evaluation and Mitigation Strategies
(REMS) and/or substantively limit the product label. Furthermore,
the timing of any action by the FDA and possible regulatory paths
forward cannot be guaranteed, in that, for example: (i) the FDA may
miss its own required deadlines (including the target action date
assigned under the Prescription Drug User-Fee Act, or "PDUFA"); and
(ii) the FDA may require further information or additional clinical
studies. Finally, no statement provided herein should be understood
to provide an estimate of the market potential for Brinavess in
the United States.
A detailed discussion of the risks and uncertainties facing
Correvio are discussed in the annual report 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 Correvio's Annual Report on Form 40-F
for the year ended December 31, 2018
and its quarterly report filed November 14,
2019 for the third quarter of 2019. All of the risks and
certainties disclosed in those filings are hereby incorporated by
reference in their entirety into this news release.
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. Investors are cautioned that forward-looking
statements are not guarantees of future performance and accordingly
investors are cautioned not to put undue reliance on
forward-looking statements due to their inherent uncertainty.
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.
Trevyent® is a trademark of SteadyMed Ltd., a subsidiary
of United Therapeutics Corporation and used under license.
All other trademarks are the property of their respective
owners.
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SOURCE Correvio Pharma Corp