EU Approves Sanofi’s Plavix (Clopidogrel) in Combination with Aspirin for Specific Types of Stroke
Feb 14, 2021 21:33
CST Updated
21:33
Sanofi
Pharmaceutical R&D Developer
European Commission
The European Commission, abbreviated as the EU Commission, is a supranational body under the European Union. Within the EU political system, the European Commission primarily undertakes executive tasks, thus being roughly equivalent to the government in a national system. However, the European Commission has other functions as well. In particular, except for the few circumstances specified in the treaties, the European Commission is the only institution with legislative power in the EU legislative process.
February 14, 2021 News /BioValleyBIOON/ -- Sanofi recently announced that the European Commission (EC) has approved a new indication for Plavix (brand name: Plavix; generic name: clopidogrel): the combination of Plavix and aspirin for the treatment of adult patients with moderate-to-high risk transient ischemic attack (TIA) (ABCD2 score ≥4) or minor ischemic stroke (IS) (NIHSS ≤3) within 24 hours after the onset of a TIA or IS event. This new indication includes a 21-day course of combined therapy with Plavix and aspirin initiated within 24 hours of symptom onset, followed by long-term monotherapy with an antiplatelet agent.
Plavix is an antiplatelet drug that was first approved in the European Union in 1998 for use in patients with ischemicStroke, patients with a history of myocardial infarction and peripheral vascular disease, reduceStroke, the risk of myocardial infarction and cardiovascular death. It is worth mentioning that Plavix was the first ADP receptor antagonist approved in the European Union.
Since the launch of Plavix 20 years ago, it has been used in various vascular diseases by more than 200 million patients, either with or without aspirin. Over 250,000 patients have been studied in cardiovascular outcomes trials (CVOTs).
This additional indication is based on two double-blind, randomized, placebo-controlled, investigator-initiated Phase 3Clinical Trialsresults. These two trials involved more than 10,000 patients, and the results showed that the combination of Plavix and aspirin in reducing subsequentStrokesuperior to aspirin monotherapy in terms of risk, with an acceptable overall safety profile.
The POINT study evaluated combined treatment with Plavix and aspirin in 4,881 patients from an international population. The results showed that, compared with patients treated with aspirin alone, those receiving combined Plavix and aspirin therapy had a 25% reduction in the number of patients experiencing serious ischemic events (5.0% vs. 6.5%; HR: 0.75; 95% CI: 0.59–0.95; p=0.02).
In the CHANCE study, 5,170 Chinese patients with first-ever minor ischemic stroke (IS) or high-risk transient ischemic attack (TIA) were treated. The results showed that within 90 days, compared with patients taking aspirin alone, those receiving combination therapy with Plavix and aspirin experienced subsequentStrokeThe number of patients was significantly reduced by 32% (8.2% vs 11.7%; HR=0.68; 95% CI: 0.57-0.81; p<0.001).
Dr. Sandra Silvestri, Global Head of General Medicines at Sanofi, stated, “For patients who have just experienced a minor ischemic stroke (IS) or a moderate-to-high-risk transient ischemic attack (TIA), appropriate early intervention is crucial to reduce the risk of subsequent stroke, which is particularly high in the initial weeks. This new indication reflects our unwavering commitment to advancing cardiovascular therapy. Plavix was the first drug of its kind approved for use in the European Union, and more than 20 years later, we are proud to continue expanding its clinical applications.” (Bioon.com)
Original Source: New indication for Plavix® (clopidogrel) nowapproved in the European Union