CHMP recommends approval of Plavix® (clopidogrel) with aspirin in adults for certain types of strokes
12 December 2020 - 12:30AM
CHMP recommends approval of Plavix® (clopidogrel) 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
- Positive opinion based on clinical data demonstrating
combination therapy with Plavix provided greater protection against
subsequent stroke than aspirin alone
PARIS – December 11, 2020 – 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
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,1,2 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 risk of ischemic stroke is an
immediate priority in patients experiencing minor IS or high-risk
TIA, as risk of recurrence is particularly high in the first few
weeks,” said Sandra Silvestri, M.D., Ph.D., Global Head of Medical,
General Medicines at Sanofi. “This new indication builds on 20
years of use of Plavix in secondary prevention of atherothrombosis,
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 study2
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 study1, 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.
Following this CHMP positive opinion, a final
decision about the new, expanded indication is anticipated in Q1
2021.
Editor’s Note: Plavix was first approved in the
E.U. in 1998 for the reduction of stroke, myocardial infraction and
vascular death in patients with a history of ischemic stroke,
myocardial infarction, and peripheral vascular disease. The
antiplatelet medicine was the first ADP receptor antagonist to be
approved in the E.U.
1. Wang Y et al.,
2013, N Engl J Med 2013; 369:11-19, DOI: 10.1056/NEJMoa1215340.
2. Johnston SC et al., 2018, N Engl J
Med 2018; 379:215-225, DOI: 10.1056/NEJMoa1800410.
About Sanofi Sanofi is dedicated to
supporting people through their health challenges. We are a global
biopharmaceutical company focused on human health. We prevent
illness with vaccines, provide innovative treatments to fight pain
and ease suffering. We stand by the few who suffer from rare
diseases and the millions with long-term chronic
conditions. With more than 100,000 people in 100 countries,
Sanofi is transforming scientific innovation into healthcare
solutions around the globe. Sanofi, Empowering Life |
Media
Relations Contacts Ashleigh Koss Tel: +1 (908)
981-8745Ashleigh.Koss@sanofi.com Investor Relations
Contacts Paris Eva Schaefer-Jansen Arnaud DelepineYvonne
Naughton Investor Relations Contacts North
America Felix LauscherFara BerkowitzSuzanne Greco IR
main line:Tel.: +33 (0)1 53 77 45 45 ir@sanofi.com |
Sanofi Forward-Looking
StatementsThis press release contains forward-looking
statements as defined in the Private Securities Litigation Reform
Act of 1995, as amended. Forward-looking statements are statements
that are not historical facts. These statements include projections
and estimates regarding the marketing and other potential of the
product, or regarding potential future revenues from the product.
Forward-looking statements are generally identified by the words
“expects”, “anticipates”, “believes”, “intends”, “estimates”,
“plans” and similar expressions. Although Sanofi’s management
believes that the expectations reflected in such forward-looking
statements are reasonable, investors are cautioned that
forward-looking information and statements are subject to various
risks and uncertainties, many of which are difficult to predict and
generally beyond the control of Sanofi, that could cause actual
results and developments to differ materially from those expressed
in, or implied or projected by, the forward-looking information and
statements. These risks and uncertainties include among other
things, unexpected regulatory actions or delays, or government
regulation generally, that could affect the availability or
commercial potential of the product, the fact that product may not
be commercially successful, the uncertainties inherent in research
and development, including future clinical data and analysis of
existing clinical data relating to the product, including post
marketing, unexpected safety, quality or manufacturing issues,
competition in general, risks associated with intellectual property
and any related future litigation and the ultimate outcome of such
litigation, and volatile economic and market conditions, and the
impact that COVID-19 will have on us, our customers, suppliers,
vendors, and other business partners, and the financial condition
of any one of them, as well as on our employees and on the global
economy as a whole. Any material effect of COVID-19 on any of
the foregoing could also adversely impact us. This situation is
changing rapidly and additional impacts may arise of which we are
not currently aware and may exacerbate other previously identified
risks. The risks and uncertainties also include the uncertainties
discussed or identified in the public filings with the SEC and the
AMF made by Sanofi, including those listed under “Risk Factors” and
“Cautionary Statement Regarding Forward-Looking Statements” in
Sanofi’s annual report on Form 20-F for the year ended December 31,
2019. Other than as required by applicable law, Sanofi does not
undertake any obligation to update or revise any forward-looking
information or statements.
Sanofi (EU:SAN)
Historical Stock Chart
From Apr 2024 to May 2024
Sanofi (EU:SAN)
Historical Stock Chart
From May 2023 to May 2024