Navigation Links
FDA Reviewing Potential Anti-Arrhythmic Claims for Ranexa(R)
Date:12/7/2007

PALO ALTO, Calif., Dec. 7 /PRNewswire-FirstCall/ -- CV Therapeutics, Inc. (Nasdaq: CVTX) announced today that the U.S. Food and Drug Administration (FDA) has notified the Company that it will evaluate the approval of potential anti-arrhythmic claims for Ranexa(R) (ranolazine extended-release tablets) as part of its ongoing review of the Company's supplemental new drug application (sNDA).

This follows the FDA's acceptance of an sNDA seeking expansion to the approved product labeling for Ranexa to include a first line angina indication and a significant reduction in cautionary language as well as a separate NDA for a potential labeling change to add reduction of hemoglobin A1c (HbA1c) in coronary artery disease patients with diabetes. The two sNDAs are being reviewed by the FDA Division of Cardiovascular and Renal Products and the NDA is being reviewed by the FDA Division of Metabolism and Endocrinology Products.

The Prescription Drug User Fee Act (PDUFA) action date for the sNDAs and the NDA is July 27, 2008. The FDA has requested, and CV Therapeutics has paid three separate user fees to support the review of both sNDAs and the NDA.

"We anticipate receiving approval for first line angina use, which would significantly expand the patient population eligible to receive Ranexa, and we are very pleased that the FDA also is now evaluating separate potential anti- arrhythmic and HbA1c reduction claims for Ranexa on the same timeline," said Louis G. Lange, CV Therapeutics chairman and chief executive officer.

In September 2007, data published in Circulation and presented at the European Society of Cardiology Congress 2007 in Vienna, Austria showed that Ranexa reduced ventricular arrhythmias in patients receiving Ranexa compared to placebo in the MERLIN TIMI-36 study.

Patients receiving Ranexa had a 37 percent reduction in their relative risk of ventricular tachycardia lasting eight beats or more (p<0.001) and there were fewer episodes of sudden cardiac death observed in patients taking ranolazine (56) than in patients taking placebo (65).

In accordance with a special protocol assessment agreement between the FDA and CV Therapeutics, the Company believes that data from the MERLIN TIMI-36 study could support expansion of the existing Ranexa indication to first line angina.

Ranexa is currently indicated for the treatment of chronic angina in patients who have not achieved an adequate response with other antianginal drugs, and should be used in combination with amlodipine, beta-blockers or nitrates.

About CV Therapeutics

CV Therapeutics, Inc., headquartered in Palo Alto, California, is a biopharmaceutical company focused on applying molecular cardiology to the discovery, development and commercialization of novel, small molecule drugs for the treatment of cardiovascular diseases.

CV Therapeutics' approved product, 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, and should be used in combination with amlodipine, beta-blockers or nitrates.

CV Therapeutics' clinical and preclinical drug development candidates and programs include regadenoson, which is being developed for potential use as a pharmacologic stress agent in myocardial perfusion imaging studies, and CVT- 6883, which is being developed as a potential treatment for cardiopulmonary diseases. Regadenoson and CVT-6883 have not been determined by any regulatory authorities to be safe or effective in humans for any use.

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 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, 2007. CV Therapeutics disclaims any intent or obligation to update these forward-looking statements.


'/>"/>
SOURCE CV Therapeutics, Inc.
Copyright©2007 PR Newswire.
All rights reserved

Related medicine news :

1. InstaCare Corp. Reviewing M&A Plans
2. Thomson Scientific Publishes its Third Quarter Issue of the Ones to Watch Reviewing the Most Promising Drugs in the Pharmaceutical Pipeline
3. DNA vaccine against multiple sclerosis appears safe, potentially beneficial
4. UCLA study identifies designer estrogen as potential MS drug
5. Office-Based Medical Treatment and Internet Resources Are Potential Solution to Rising Painkiller Misuse Among Teens, Young Adults
6. Common abdominal pain may be due to a potentially treatable newly recognized inflammatory reaction
7. Potential new approach to treat cognitive impairments in schizophrenia
8. Nosespray vaccine using aloe vera has exciting potential, researcher says
9. Network approach identifies potential breast cancer susceptibility gene
10. Liver fibrosis will be treated by a potential target
11. Researchers study potential health benefits of natural chemicals in muscadine grape seeds
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:4/28/2017)... ... April 28, 2017 , ... Accreditation Commission for ... Care Association of America (HCAOA). This agreement allows HCAOA members to receive special ... as discounts on Accreditation University (AU) educational resources that help prepare HCAOA members ...
(Date:4/28/2017)... , ... April 28, 2017 , ... Horizon Blue Cross ... the company’s credit rating of “A” and its outlook as “stable.” At the same ... reserves, which have fallen in recent years, dip below “capital adequacy” thresholds required for ...
(Date:4/28/2017)... , ... April 28, 2017 , ... ... Replace tubes . These lamps offer an instant energy-saving solution for F32T8 fluorescent ... rewire fixtures or disconnect ballasts. These 50,000 hour rated lamps utilize the existing ...
(Date:4/28/2017)... ... April 28, 2017 , ... The Texas Cord Blood Bank (TCBB), a program ... delivery team at Women’s Hospital at Renaissance in Edinburg for their outstanding efforts in ... and decide to donate. , “Women’s Hospital at Renaissance has been a collection ...
(Date:4/28/2017)... ... April 28, 2017 , ... Bill Howe started his sewer and drain ... After Tina Howe joined the team, the Bill Howe brand was born and they ... rates, and giving back to the San Diego community in which they worked, lived ...
Breaking Medicine News(10 mins):
(Date:4/20/2017)... DUBLIN , April 20, 2017 Research ... Delivery Technologies - Innovation Driven by Rapidly Expanding Injectables Market and ... to their offering. ... market for drug delivery technologies will rise from USD 20 Billion ... Global Drug Delivery Technologies - Innovation Driven by Rapidly ...
(Date:4/20/2017)... Research and Markets has announced the ... Application Analysis, Regional Outlook, Growth Trends, Key Players, Competitive Strategies ... ... was valued at US$ 7,167.6 Mn in 2015, and is ... a CAGR of 5.6% from 2016 to 2024. ...
(Date:4/19/2017)... 19, 2017 /PRNewswire/ - CRH Medical Corporation (TSX: CRH) (NYSE MKT: CRHM) (the ... Co. Healthcare Investor Conference 2017 at the Sheraton Hotel in ... Chief Executive Officer of the Company is scheduled to present on ... Bear and the Chairman of the Board, Tony Holler ... ...
Breaking Medicine Technology: