FDA Grants Priority Review To Supplemental New Drug Application Filed For Plavix® By Sanofi-Synthelabo and Bristol-Myers Squibb

11-Sep-2001

PARIS and PRINCETON, NEW JERSEY (September 10, 2001) -- Sanofi-Synthelabo and Bristol-Myers Squibb Company announced that the supplemental new drug application (sNDA) for Plavix® (clopidogrel bisulfate) has been granted priority review by the U.S. food and Drug Administration (FDA). Under priority review, new drug applications are reviewed within six months.

The supplemental filing for clopidogrel is based on the positive results of the landmark CURE (Clopidogrel in Unstable Angina to Prevent Recurrent Events) study, recently published in the New England Journal of Medicine.1 CURE demonstrated that initiating therapy early with clopidogrel, on top of standard therapy including ASA (or aspirin), and continuing its use long term, significantly reduced the risk of heart attack, stroke and cardiovascular death by 20 percent in patients with acute coronary syndrome (unstable angina and non-Q wave myocardial infarction) (p = 0.00009) compared with patients who received standard therapy (including ASA) alone.

In the study, the benefits of clopidogrel were seen within hours and continued to increase throughout the entire study duration of 12 months.

The CURE results also confirmed clopidogrel's overall safety profile. The risk of major bleeding was 3.7 percent when clopidogrel was used on top of standard therapy (including ASA), compared to 2.7 percent with standard therapy (including ASA) alone.

Plavix is currently indicated for the reduction of atherosclerotic events (myocardial infarction, stroke, and vascular death) in patients with atherosclerosis documented by recent stroke, recent myocardial infarction, or established peripheral arterial disease.

https://www.chemeurope.com/en/news/4642/fda-grants-priority-review-to-supplemental-new-drug-application-filed-for-plavix-by-sanofi-synthelabo-and-bristol-myers-squibb.html