FDA Cardiovascular
& Renal Drugs Advisory Committee Votes That Alfuzosin is
Not Associated With a Clinically-Relevant Prolongation of the QT Interval
Sanofi-Synthélabo announced
today that the Cardiovascular & Renal Drugs Advisory Committee of the U.S. Food and
Drug Administration (FDA) voted unanimously (with one member abstaining) that the Companys
clinical investigations showed that alfuzosin is not associated with a
clinically-relevant prolongation of the QT interval. Alfuzosin is an alpha1-blocker in a
10 mg once-daily extended release formulation being reviewed by the FDA for the treatment
of signs and symptoms of benign prostatic hyperplasia.
Sanofi-Synthélabo presented
results from clinical trials specifically designed to measure potential changes to the QT
interval. The QT interval is one of the parameters measured in an ECG
(Electrocardiogram), which reflects cardiac repolarization (or time for the heart to
electrically recharge).
These data were supported by an
extensive worldwide safety database from over 15 years of clinical experience, which
translates into 1.35 billion days (3.7 million patient years) of patient therapy.
Alfuzosin, a compound from Sanofi-Synthélabo research, is marketed throughout
Europe, Latin America, Africa and Asia in more than 80 countries. The once-daily
formulation (Xatral® OD) is registered in 70 countries worldwide; it is currently
marketed in 14 countries in Europe and in more than 35 other countries.
The committees recommendation
will be considered by the FDA in its final review of the new drug application (NDA),
which Sanofi-Synthélabo submitted in December 2000 and for which Sanofi-Synthélabo
received an approvable letter in October 2001.
Benign prostatic hyperplasia is a
very common disorder, leading to urinary symptoms of varying severity. The resulting
moderate to severe symptoms affect 22% of men aged 50-59 years, but up to 45% of men aged
70-80 years. These symptoms have a significant impact on quality of life including
sexuality and may lead to serious complications such as acute urinary retention. Clinical
efficacy data for alfuzosin from three placebo-controlled trials were previously
submitted to the FDA and demonstrated efficacy compared to placebo in urinary flow
improvement without the need for dose titration.
About Sanofi-Synthélabo
Sanofi-Synthelabo is a major global
research-based pharmaceutical group with 32,500 employees in more than 100 countries. The
company is headquartered in Paris and listed in Paris (Euronext : SAN) and in New York
(NYSE : SNY). With consolidated sales of EUR 7.4 billion in 2002, Sanofi-Synthelabo ranks
7th in Europe and among the worlds top 20 pharmaceutical companies. With an R&D
portfolio of 52 compounds in development, Sanofi-Synthelabo is focused on a core group of
four therapeutic areas: cardiovascular disease and thrombosis; diseases of the central
nervous system; internal medicine; and oncology.
Forward Looking Statement
This release contains statements
that constitute forward-looking statements within the meaning of the U.S. Private
Securities Litigation Reform Act of 1995. These statements are based on managements
current expectations or beliefs and are subject to a number of factors and uncertainties
that could cause actual results to differ materially from those described in the
forward-looking statements. The following factors, among others, could cause actual
results to differ materially from those described in the forward-looking statements : the
ability of Sanofi-Synthélabo to expand its presence profitably in the United
States; the success of Sanofi-Synthélabos research and development programs;
the ability of Sanofi-Synthélabo to protect its intellectual property rights; and
the risks associated with reimbursement of health care costs and pricing reforms,
particularly in the United States and France.
Investors and security holders may
obtain a free copy of documents filed by Sanofi-Synthélabo with the U.S.
Securities and Exchange Commission at www.sec.gov or directly from Sanofi-Synthélabo
on the web site www. sanofi-synthelabo.com
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