Following this positive recommendation from the CHMP, CV Therapeutics expects the European Commission to issue full marketing authorization for ranolazine by the end of June. The brand name for ranolazine in the product labeling is Latixa(TM).
The approved indication states that ranolazine "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 antianginal therapies (such as beta-blockers and/or calcium antagonists)."
The 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 calcium overload is expected to improve myocardial relaxation and decrease left ventricular diastolic stiffness. The doses of the product in the EU will be 375 mg, 500 mg and 750 mg twice daily.
"This positive opinion from the CHMP brings ranolazine significantly
closer to physicians and patients 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 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:
ability of CV Therapeutics to achieve profitability; 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; reliance on strategic collaborative
partners; reliance on contract manufacturers; intellectual property; and other
risks detailed from time to time in CV Therapeutics' SEC reports, including
its Annual Report on Form 10-K for the year ended
SOURCE CV Therapeutics, Inc.