CHMP Recommends Approval of Plavix® (Clopidogrel) in Combination with Aspirin for Treatment of High-Risk TIA and Minor Ischemic Stroke in Adults

Dec 16, 2020 18:57 CST Updated 18:57

Sanofi

Pharmaceutical R&D Developer

Committee for Medicinal Products for Human Use

Committee for Medicinal Products for Human Use (CHMP)The Committee for Medicinal Products for Human Use (CHMP) is the committee within the European Medicines Agency (EMA) responsible for human medicines. The CHMP replaced the former Committee for Proprietary Medicinal Products (CPMP) in May 2004.The CHMP plays a vital role in the authorization of medicines in the European Union (EU). In the centralized procedure, the CHMP is responsible for: 1) conducting initial assessments of marketing authorization applications across the EU; assessing modifications or extensions to existing marketing authorizations (“variations”); considering recommendations from the Agency’s Pharmacovigilance Risk Assessment Committee regarding the safety of medicines on the market, and, where necessary, advising the European Commission to amend the marketing authorization of a medicinal product, or to suspend or withdraw it from the market.The CHMP also evaluates medicines authorized at the national level that are referred to the EMA, with the aim of maintaining a harmonized position throughout the EU.Furthermore, the CHMP and its working groups promote the development of medicines and pharmaceutical regulation by: providing scientific advice to companies researching and developing new medicines; developing scientific and regulatory guidelines to assist pharmaceutical companies in preparing marketing authorization applications for human medicines; and collaborating with international partners to harmonize regulatory requirements.

December 16, 2020 News /BioValleyBIOON/ -- Sanofi recently announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion, recommending the approval of a new indication for Plavix (brand name: Plavix; generic name: clopidogrel): for the treatment of adult patients at high risk of transient ischemic attack (TIA) or minor ischemic stroke (IS). This new indication includes the combined use of Plavix and aspirin within 24 hours of symptom onset, continued for 21 days, 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 noting that Plavix was the first ADP receptor antagonist approved in the European Union.

This additional indication is based on two double-blind, randomized, placebo-controlled, investigator-initiated Phase 3Clinical Trialresults. These two trials involved more than 10,000 patients, and the results showed that the combination of Plavix and aspirin reduced subsequentStrokesuperior to aspirin monotherapy in terms of risk, with an acceptable overall safety profile.

The POINT study evaluated combination therapy with Plavix and aspirin in 4,881 patients from an international population, and the results showed that, compared with patients receiving aspirin monotherapy,The number of patients experiencing serious ischemic events was reduced by 25% in those receiving combined treatment with Plavix and aspirin.（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 to patients taking aspirin alone,Subsequent Events in Patients Treated with Plavix and Aspirin Combination TherapyStrokethe number of patients significantly decreased 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 Sanofi General Medicines, stated: “For patients who have experienced a minor ischemic stroke (IS) or are at high risk for transient ischemic attack (TIA), reducing the risk of ischemic stroke is a top priority, as the risk of recurrence is particularly high in the initial weeks. This new indication builds on 20 years of secondary prevention experience with Plavix in atherothrombotic conditions (such as ischemic stroke or acute coronary syndrome), reflecting Sanofi’s unwavering commitment to advancing care for patients with cardiovascular disease.”(Bioon.com)

Original Source: CHMP recommendsapproval of Plavix® (clopidogrel) with aspirin in adults for certain types of strokes