CV Therapeutics Receives Approvable Letter for Ranexa(TM)
October 30 2003 - 5:19PM
PR Newswire (US)
CV Therapeutics Receives Approvable Letter for Ranexa(TM) Advisory
Committee Scheduled to Review Ranexa December 9, 2003 PALO ALTO,
Calif., Oct. 30 /PRNewswire-FirstCall/ -- CV Therapeutics, Inc.
announced today that it has received an approvable letter from the
U.S. Food and Drug Administration (FDA) for its New Drug
Application (NDA) for Ranexa(TM) (ranolazine) for the treatment of
chronic angina. The Cardiovascular and Renal Drugs Advisory
Committee is scheduled to review Ranexa on December 9, 2003. CV
Therapeutics understands, based on discussions with the FDA, that
the purpose of the advisory committee meeting is to determine
whether the committee considers the current NDA sufficient to
support approval of Ranexa. In the approvable letter, the FDA
indicated that there is evidence that Ranexa is an effective
anti-anginal, and that additional clinical information is needed
prior to approval. We understand that the FDA may be prepared to
reevaluate this requirement based on the results of the advisory
committee review. The FDA is not required to follow the
recommendations of the advisory committee. "We are pleased that the
FDA has requested the input of the advisory committee as it
evaluates Ranexa. There has not been a new class of therapy for
angina introduced in the United States in more than 20 years, and
we believe that Ranexa could address the significant need for new
treatment options for angina patients," said Louis G. Lange, M.D.,
Ph.D., chairman and chief executive officer of CV Therapeutics.
None of CV Therapeutics' products have been approved for marketing
by the FDA or foreign regulatory agencies. Any products of the
company discussed here are currently under investigation in
clinical trials subject to United States Investigational New Drug
applications, and as applicable, appropriate clinical trial
applications to regulatory authorities outside the United States.
CV Therapeutics' products have not been determined to be safe or
effective in humans for any uses. 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 currently has four compounds in clinical trials. If
approved by the FDA, Ranexa would represent the first new class of
anti-anginal therapy in more than 20 years. Tecadenoson, an
A1-adenosine receptor agonist, is being developed for the potential
reduction of rapid heart rate during atrial arrhythmias. CVT-3146,
a selective A2A-adenosine receptor agonist, is being developed for
potential use as a pharmacologic stress agent in cardiac perfusion
imaging studies. Adentri(TM), an A1-adenosine receptor antagonist
for the potential treatment of acute and chronic congestive heart
failure, is licensed to Biogen, Inc. For more information, please
visit CV Therapeutics' website at http://www.cvt.com/ . Except for
the historical information contained herein, the matters set forth
in this press release, including statements as to development and
commercialization of the company's 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,
early stage of development; the timing of clinical trials; the
dependence on collaborative and licensing agreements; approval and
commercialization of our products; and other risks detailed from
time to time in CVT's SEC reports, including its Annual Report on
Form 10-K for the year ended December 31, 2002, and its most recent
Quarterly Report on Form 10-Q. CVT disclaims any intent or
obligation to update these forward-looking statements. DATASOURCE:
CV Therapeutics, Inc. CONTACT: Investor Contacts: Dan Spiegelman,
SVP & Chief Financial Officer, +1-650-384-8509, or Christopher
Chai, Treasurer & Executive Director, Investor Relations,
+1-650-384-8560, or Media Contacts: John Bluth, Director, Corporate
Communications, +1-650-384-8850, all of CV Therapeutics, Inc.; or
Carol Harrison of Fleishman-Hillard, +1-212-453-2442, for CV
Therapeutics, Inc. Web site: http://www.cvt.com/
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