CHMP recommends approval of Plavix with aspirin in adults for certain types of strokes

▴ CHMP recommends approval of Plavix with aspirin in adults for certain types of strokes
CHMP issues positive opinion for use of Plavix with aspirin in adults within 24 hours of minor ischemic stroke or high-risk transient ischemic attack

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for an additional indication for Plavix (clopidogrel) in adult patients with a high-risk transient ischemic attack (TIA) or minor ischemic stroke (IS). This new indication includes Plavix used alongside aspirin within 24 hours of an event and continued for 21 days, followed by long-term single anti-platelet therapy.

The additional indication is based on the results of two double-blind, randomized, placebo-controlled investigator-initiated Phase 3 trials involving more than 10,000 patients, which showed that the combination of Plavix and aspirin initiated within 24 hours is superior to aspirin alone for reducing the risk of subsequent stroke, with an overall acceptable safety profile.

“Reducing the risk of ischemic stroke is an immediate priority in patients experiencing minor IS or high-risk TIA, as the risk of recurrence is particularly high in the first few weeks,” said Sandra Silvestri, M.D., PhD, Global Head of Medical, General Medicines at Sanofi. “This new indication builds on 20 years of use of Plavix in secondary prevention of atherothromboses, such as ischemic stroke or acute coronary syndrome, and reflects Sanofi’s unwavering commitment to advance care for people living with a cardiovascular disease.”

In an international population, the POINT study tested the combination of Plavix and aspirin on 4,881 patients, finding that 25% fewer people suffered major ischemic events after treatment with Plavix and aspirin compared with treatment with aspirin alone (5.0% vs 6.5%; HR: 0.75; 95% CI: 0.59 to 0.95; p=0.02).

In the CHANCE study, which randomized 5,170 patients in China after an initial minor IS or high-risk TIA event, 32% fewer people treated with Plavix and aspirin suffered subsequent strokes compared with those treated with aspirin alone (8.2% vs 11.7%; Hazard ratio (HR): 0.68; 95% confidence interval (CI): 0.57 to 0.81; p<0.001) at 90 days.

Tags : #Sanofi #LatestNewsonSanofi12thDec #LatesPharmaNews12thDec #EuropeanMedicinesAgency #LatestTreatmentforIschemicAttack12thDec

About the Author


Team Medicircle

Related Stories

Loading Please wait...

-Advertisements-




Trending Now

Scars That Never Heal: The Painful Reality of Female Genital MutilationFebruary 06, 2025
Maharashtra’s Healthcare Betrayal: Why Are Crucial Funds Going Unused?February 06, 2025
1vision, 1 mission: Avaada Foundation’s CSR initiatives are powering communities and delivering sustainable progress across 5 key focus areasFebruary 06, 2025
Top 5 Technology Brands that are Transforming the Cancer Care Journeys for Hospitals and PatientsFebruary 06, 2025
Women's Wellness brand NUA Raises Rs 35 Crore in Pre-Series C led by Mirabilis Investment TrustFebruary 06, 2025
8 Effective Ways to Minimize Postpartum ComplicationsFebruary 06, 2025
Does Where You Live Decide Your Fate? The Urban-Rural Breast Cancer Divide in IndiaFebruary 06, 2025
Nepal leads the world with largest pictorial health warnings on all tobacco productsFebruary 05, 2025
Fleetguard Filters Private Limited Recognized for Excellence in CSR at Navabharat’s 4th CSR ConclaveFebruary 05, 2025
Six new regions of the Russian Federation are set to connect to Moscow's AI medical services platform, MosMedAIFebruary 04, 2025
Six new regions of the Russian Federation are set to connect to Moscow's AI medical services platform, MosMedAIFebruary 04, 2025
Ashok Leyland Reinforces ESG Commitment, Ranked No. 1 Globally in Sustainalytics’ RatingsFebruary 04, 2025
Calcium Supplements: Do You Really Need Them?February 04, 2025
Digital Diagnostics Doubles Its Foreign Publication Count in 2024February 04, 2025
World Cancer Day quotesFebruary 04, 2025
India can take a big leap in Cancer Care with Improved access to treatment and People-centered Approach: ExpertsFebruary 04, 2025
Lilly India appoints Winselow Tucker as the President and General ManagerFebruary 04, 2025
Driving Excellence in Clinical Research: ISCR's 18th Annual Conference Highlights Innovation, Technology, and Patient-CentricityFebruary 04, 2025
Southern Cross University introduces Access25 initiative to make international education more accessible to Indian studentsFebruary 04, 2025
Why Millions Suffer from Ineffective Treatments And the New Science That Can Save ThemFebruary 04, 2025