FDA Approves Ranexa(R) for First Line Anti Anginal Use and Adds New Claims for Reduction of Ventricular Arrhythmias, Bradycardia
November 06 2008 - 6:00AM
PR Newswire (US)
- New labeling reinforces strong safety profile of Ranexa - PALO
ALTO, Calif., Nov. 6 /PRNewswire-FirstCall/ -- CV Therapeutics,
Inc. (NASDAQ:CVTX) announced today that the U.S. Food and Drug
Administration (FDA) has approved a new, first line indication for
Ranexa(R) (ranolazine extended-release tablets) for the treatment
of chronic angina. The new labeling also provides information
showing that Ranexa reduced arrhythmias including ventricular
arrhythmias, new onset atrial fibrillation and a potentially
dangerous slow heartbeat known as bradycardia in patients with
coronary artery disease. In addition, the new labeling states that
Ranexa reduces hemoglobin A1c (HbA1c) in patients with diabetes.
According to the revised labeling, Ranexa is indicated for the
treatment of chronic angina and may be used alone or in combination
with traditional therapies for chronic angina, such as beta
blockers, calcium channel blockers and nitrates, and common
cardio-protective treatments for cardiovascular disease such as
anti-platelet therapy, lipid-lowering therapy, ACE inhibitors and
angiotensin receptor blockers. Ranexa may now be used as part of an
optimal medical therapy regimen for chronic angina patients,
regardless of whether or not they receive a stent or other medical
intervention. Ranexa does not reduce heart rate or blood pressure
and, unlike long acting nitrates, Ranexa can be prescribed for
patients taking oral erectile dysfunction treatments. "This
important FDA action allows the benefits of Ranexa to be extended
to more patients. The new labeling clearly describes the
substantial proven safety and efficacy of Ranexa for the treatment
of chronic angina, the debilitating cardiac chest pain that affects
more than nine million Americans each year," said Louis G. Lange,
CV Therapeutics chairman and chief executive officer. "Ranexa is a
very well tolerated drug that can now be considered among the first
drugs to be given to patients with chronic angina. Our commercial
organization will actively focus on educating new and existing
prescribers about these significant new labeling improvements,"
Lange added. The most frequently reported adverse reactions during
treatment with Ranexa in clinical trials were dizziness, headache,
constipation and nausea. Complete updated prescribing information
will be available at http://www.ranexa.com/. "Ranolazine may now
take optimal medical therapy to an entirely new level, and may
afford enhanced symptom relief," said Dr. William Boden, clinical
chief, division of cardiovascular medicine, University at Buffalo
Schools of Medicine & Public Health and principal investigator
of the COURAGE study. "I have seen excellent safety, tolerability
and symptom relief in the great majority of chronic angina patients
for whom I have prescribed ranolazine," he added. "As we have seen
in the MERLIN-TIMI 36 trial and in clinical practice, patients with
ischemia and angina can be at increased risk for arrhythmias and
also often have diabetes. Considering its mechanism of action,
established cardiovascular safety and observed reductions in
arrhythmias and HbA1c, ranolazine now becomes an even more
important drug in our treatment of chronic angina," said Dr. Eugene
Braunwald, Distinguished Hersey Professor of Medicine at Harvard
Medical School and chairman of the TIMI Study Group. These
significant new labeling changes were supported by a supplemental
new drug application submitted in September 2007 that included data
from the 6,560 patient MERLIN-TIMI 36 trial, which showed no
adverse trend in death or arrhythmia in a high risk acute coronary
syndromes patient population. The revised labeling includes new
language noting that there was a significantly lower incidence of
arrhythmias (ventricular tachycardia, bradycardia, supraventricular
tachycardia and new atrial fibrillation) in patients treated with
Ranexa versus placebo. This difference in arrhythmias did not lead
to a reduction in mortality, a reduction in arrhythmia
hospitalization or a reduction in arrhythmia symptoms. The revised
labeling also includes new language noting that Ranexa produces
small reductions in HbA1c. Though Ranexa should not be considered a
treatment for diabetes, Ranexa may be a particularly useful
medication for the reduction of chronic angina in this patient
population, which is difficult to treat because some anti anginal
medications such as beta blockers increase HbA1c. More than 150,000
patients have been prescribed Ranexa since its initial launch in
March 2006. Conference Call Company management will webcast a
conference call to discuss the FDA approval and third quarter 2008
financial results on Thursday, November 6 at 8:00 a.m. EST, 5:00
a.m. PST, on the Company's website. To access the live webcast,
please log on to the Company's website at http://www.cvt.com/ and
go to the Investor Information section. Alternatively, domestic
callers may participate in the conference call by dialing (866)
524-6241, and international callers may participate in the
conference call by dialing (706) 679-3061. Webcast and telephone
replays of the conference call will be available approximately two
hours after the completion of the call through Thursday, November
13. Domestic callers can access the replay by dialing (800)
642-1687, and international callers can access the replay by
dialing (706) 645-9291; the PIN access number is 68392680. About
Ranexa(R) In the United Sates, Ranexa is indicated for the
treatment of chronic angina. Ranexa may be used with beta blockers,
nitrates, calcium channel blockers, anti-platelet therapy,
lipid-lowering therapy, and ACE inhibitors. In the European Union,
Ranexa (ranolazine prolonged-release tablets) is indicated as
add-on therapy for the symptomatic treatment of patients with
stable angina pectoris who are inadequately controlled or
intolerant to first-line anti anginal therapies. CV Therapeutics
has granted the Menarini Group an exclusive license to
commercialize Ranexa in Europe, among other specified territories.
About CV Therapeutics CV Therapeutics, Inc., headquartered in Palo
Alto, California, is a biopharmaceutical company primarily focused
on applying molecular cardiology to the discovery, development and
commercialization of novel, small molecule drugs for the treatment
of cardiovascular diseases. CV Therapeutics Ltd. is the company's
European subsidiary based in the United Kingdom. CV Therapeutics'
approved products in the United States include Ranexa(R)
(ranolazine extended-release tablets), indicated for the treatment
of chronic angina, and Lexiscan(R) (regadenoson) injection for use
as a pharmacologic stress agent in radionuclide myocardial
perfusion imaging in patients unable to undergo adequate exercise
stress. Ranexa(R) (ranolazine prolonged-release tablets) is
approved for use in the European Union as add-on therapy for the
symptomatic treatment of patients with stable angina pectoris who
are inadequately controlled or intolerant to first-line anti
anginal therapies. CV Therapeutics also has other clinical and
preclinical drug development candidates and programs. Except for
the historical information contained herein, the matters set forth
in this press release, including statements as to research and
development and commercialization of products, are forward-looking
statements within the meaning of the "safe harbor" provisions of
the Private Securities Litigation Reform Act of 1995. These
forward-looking statements are subject to risks and uncertainties
that may cause actual results to differ materially, including
operating losses and fluctuations in operating results; capital
requirements; regulatory review and approval of our products;
special protocol assessment agreement; the conduct and timing of
clinical trials; commercialization of products; market acceptance
of products; product labeling; concentrated customer base; reliance
on strategic partnerships and collaborations; uncertainties in drug
development; uncertainties regarding intellectual property and
other risks detailed from time to time in CV Therapeutics' SEC
reports, including its Quarterly Report on Form 10-Q for the
quarter ended June 30, 2008. CV Therapeutics disclaims any intent
or obligation to update these forward-looking statements.
DATASOURCE: CV Therapeutics, Inc. CONTACT: John Bluth, Executive
Director, Corporate Communications & Investor Relations for CV
Therapeutics, Inc., +1-650-384-8850 Web Site: http://www.cvt.com/
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