Ranolazine is approved for use in
The approved European labeling reflects data from the MERLIN TIMI-36 and other recently reported studies, including data showing statistically significant reductions in ventricular arrhythmias with ranolazine. The labeling also notes that the ability of ranolazine to reduce cellular calcium overload is expected to improve myocardial relaxation and decrease left ventricular diastolic stiffness.
"We expect ranolazine could be available to patients and physicians across
There are currently 48-50 million angina prescriptions written annually in
the largest five EU member countries (UK,
"Considering the well-established need for medical treatment of angina
across the EU and the unique product labeling, we believe that ranolazine may
become a leading therapy for the millions of angina patients across
About Ranolazine
In the United Sates, Ranexa(R) (ranolazine extended-release tablets) is
indicated for the treatment of chronic angina in patients who have not
achieved an adequate response with other antianginal drugs. In the U.S.,
CV Therapeutics is seeking changes to the approved product labeling for Ranexa
to include a first line angina indication, a significant reduction in
cautionary language, and the potential addition of promotable claims for the
reduction of hemoglobin A1c and ventricular arrhythmias in patients with
coronary artery disease. The Prescription Drug User Fee Act (PDUFA) action
date for these requested labeling changes is
In
About CV Therapeutics
CV Therapeutics, Inc., headquartered in
CV Therapeutics Ltd. is the company's European subsidiary based in the
CV Therapeutics' approved products in
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
SOURCE CV Therapeutics, Inc.