Sanofi-aventis And Bristol-Myers Squibb Back NICE's Decision To Review Guidance On Vascular Disease - New Evidence Could Affect Change In Guidance, UK

Main Category: Regulatory Affairs / Drug Approvals
Also Included In: Cardiovascular / Cardiology;  Pharma Industry / Biotech Industry
Article Date: 14 Aug 2008 - 3:00 PDT

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Sanofi-aventis and Bristol-Myers Squibb back today's decision by NICE (the National Institute for Health and Clinical Excellence) to review its guidance on vascular disease for clopidogrel (Plavix®) and dipyridamole. NICE originally planned to defer review of the guidance, called Technology Appraisal Number 90 (TAG90), until November 2010. During the recent NICE consultation process, a number of organisations, highlighted the pressing need for an earlier review.

"Cardiovascular diseases is Britain's number one killer, therefore it is of public interest that NICE initiates a review of this guidance. There is important new evidence available, particularly in the area of stroke, which means that the existing guidance needs to be re-assessed. We now have the opportunity to ensure the guidance is kept up to date and in line with new evidence," said Nigel Brooksby, Chairman and Managing Director, sanofi-aventis UK.

Richard Marsh, Director of External Affairs and Market Access, Bristol-Myers Squibb adds, "The review of TAG90 announced by NICE today is timely. The current guidance looks at patients in isolation, for example, patients who have only had a stroke, or patients who have only had peripheral arterial disease (PAD). However, according to the REACH registry (the largest registry of 68,000 patients with cardiovascular disease around the world), one in six of these patients have multivascular disease and are at even higher risk of further events (heart attack/stroke/hospitalisation); these multivascular patients are currently overlooked in the guidance. We look forward to participating in this review with NICE as it gives us the opportunity to ensure these patients treatment needs are addressed and that they are offered the most effective treatments."

About sanofi-aventis

Sanofi-aventis, a leading global pharmaceutical company, discovers, develops and distributes therapeutic solutions to improve the lives of everyone. Sanofi-aventis is listed in Paris (EURONEXT : SAN) and in New York (NYSE : SNY).

http://www.sanofi-aventis.com

About Bristol-Myers Squibb

Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to extend and enhance human life.

http://www.bms.com

Plavix® (clopidogrel) is manufactured by sanofi-aventis and Bristol-Myers Squibb.

The current TAG90 guidance will continue to remain in place.

References

1. NICE Technology Appraisal Guidance No 90; Vascular Disease - clopidogrel and dipyridamole. May 2005.

2. Steg PG et al. One-year cardiovascular event rates in outpatients with atherothrombosis. JAMA 2007;297(11):1197-206.

Bristol-Myers Squibb