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Biotech / Medical : CVTX - CV Therapeutics, Inc.

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To: mopgcw who wrote (78)	5/29/2003 10:03:42 PM
From: Miljenko Zuanic	Read Replies (1) of 411

I am bit lazy. Does anyone know what prolongation time we are talking here? Press Release Source: Sanofi-Synthelabo FDA Cardiovascular & Renal Drugs Advisory Committee Votes That Alfuzosin is Not Associated With a Clinically-Relevant Prolongation of the QT Interval Thursday May 29, 7:38 pm ET PARIS, May 29 /PRNewswire-FirstCall/ -- Sanofi-Synthelabo 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 Company's 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-Synthelabo 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 the 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-Synthelabo 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 Committee's recommendation will be considered by the FDA in its final review of the new drug application (NDA), which Sanofi-Synthelabo submitted in December 2000 and 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.

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