– One Application Seeks European Commission
Authorization; Other Application Would Facilitate Availability in
Low- and Lower-Middle-Income Countries –
– Both Applications Will Be Assessed in
Parallel Under Accelerated Assessment Review Timeline Based on
Potential Public Health Interest in Lenacapavir for HIV Prevention
–
– EMA Validation Follows Acceptance of U.S.
Applications by FDA Under Priority Review –
Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the
European Medicines Agency (EMA) has validated for parallel
accelerated review the company’s Marketing Authorization
Application (MAA) and EU-Medicines for all (EU-M4all) application
for lenacapavir—the company’s twice-yearly injectable HIV-1 capsid
inhibitor—for the prevention of HIV as pre-exposure prophylaxis
(PrEP).
Based on the assessment of EMA’s Committee for Medicinal
Products for Human Use (CHMP) that twice-yearly lenacapavir for
prevention is a product of major interest for public health and
therapeutic innovation, both applications will be assessed under an
accelerated assessment review timeline.
The EU MAA will be reviewed by the CHMP under the centralized
licensing procedure for all 27 Member States of the European Union,
as well as Norway, Iceland and Liechtenstein. The EU-M4all
application will be reviewed in parallel with the MAA and seeks a
CHMP opinion that can be leveraged by national regulatory agencies
outside the EU, including in low- and-lower-middle-income
countries, to facilitate more expedited review processes in their
respective countries and potentially accelerate access to
lenacapavir for PrEP.
The EMA validation follows the announcement last week that the
U.S. Food and Drug and Administration (FDA) accepted Gilead’s New
Drug Applications (NDAs) for lenacapavir for PrEP and will assess
them under priority review.
“Achieving another key regulatory milestone so soon after the
U.S. FDA’s acceptance of our New Drug Applications for lenacapavir
for PrEP underscores the great interest in how this medication, if
approved, could help transform efforts to end the HIV epidemic
globally,” said Dietmar Berger, MD, PhD, Chief Medical Officer,
Gilead Sciences.
The EMA applications are supported by data from the Phase 3
PURPOSE 1 and PURPOSE 2 trials conducted by Gilead. In PURPOSE 1
(NCT04994509), data showed twice-yearly lenacapavir demonstrated
zero infections in the lenacapavir group and 100% risk reduction
and superiority compared to background HIV incidence (bHIV) for the
investigational use of HIV prevention in cisgender women. In
PURPOSE 2 (NCT04925752), there were two HIV infections in the
lenacapavir group, demonstrating 99.9% of participants in the
lenacapavir group did not acquire HIV infection, a 96% risk
reduction in HIV infections, and superiority compared to bHIV among
a broad and geographically diverse range of cisgender men and
gender-diverse people. In both trials, twice-yearly lenacapavir
also demonstrated superiority of prevention of HIV infections when
compared with once-daily oral Truvada® (emtricitabine 200mg and
tenofovir disoproxil fumarate 300mg; F/TDF) and was generally
well-tolerated, with no significant or new safety concerns
identified. Based in part on these trial results, Science Magazine
in December 2024 named lenacapavir its 2024 “Breakthrough of the
Year.”
Gilead is executing an access strategy, informed by global
health advocates and organizations, that prioritizes speed and
enables the most efficient paths for the regulatory review,
approval of and access to lenacapavir for PrEP in regions around
the world.
The use of lenacapavir for the prevention of HIV is
investigational and is not approved anywhere globally.
There is currently no cure for HIV or AIDS.
About
Lenacapavir
Lenacapavir is approved in multiple countries for the treatment
of adults with multi-drug resistant HIV in combination with other
antiretrovirals. The use of lenacapavir for HIV prevention is
investigational and the safety and efficacy of lenacapavir for this
use have not been established.
The multi-stage mechanism of action of lenacapavir is
distinguishable from other currently approved classes of antiviral
agents. While most antivirals act on just one stage of viral
replication, lenacapavir is designed to inhibit HIV at multiple
stages of its lifecycle and has no known cross resistance exhibited
in vitro to other existing drug classes.
Lenacapavir is being evaluated as a long-acting option in
multiple ongoing and planned early and late-stage clinical studies
in Gilead’s HIV prevention and treatment research program.
Lenacapavir is being developed as a foundation for potential future
HIV therapies with the goal of offering both long-acting oral and
injectable options with several dosing frequencies, in combination
or as a mono agent, that help address individual needs and
preferences of people and communities affected by HIV.
About the PURPOSE
Program
Gilead’s landmark PURPOSE program is the most comprehensive and
diverse HIV prevention trial program ever conducted. The program
comprises five HIV prevention trials around the world that are
focused on innovation in science, trial design, community
engagement and health equity.
The PURPOSE trials are evaluating the safety and efficacy of an
investigational, twice-yearly injectable medicine, lenacapavir, to
reduce the chance of getting HIV. The Phase 2 and 3 program,
consisting of PURPOSE 1-5, is assessing the potential of
lenacapavir to help a diverse range of people around the world who
could benefit from PrEP.
More information about the PURPOSE program, including individual
trial descriptions, populations and locations, can be found at
www.purposestudies.com.
About Gilead HIV
For more than 35 years, Gilead has been a leading innovator in
the field of HIV, driving advances in treatment, prevention and
cure research. Gilead researchers have developed 12 HIV
medications, including the first single-tablet regimen to treat
HIV, the first antiretroviral for pre-exposure prophylaxis (PrEP)
to help reduce new HIV infections, and the first long-acting
injectable HIV treatment medication administered twice-yearly. Our
advances in medical research have helped to transform HIV into a
treatable, preventable, chronic condition for millions of
people.
Gilead is committed to continued scientific innovation to
provide solutions for the evolving needs of people affected by HIV
around the world. Through partnerships, collaborations and
charitable giving, the company also aims to improve education,
expand access and address barriers to care, with the goal of ending
the HIV epidemic for everyone, everywhere. Gilead was recognized as
one of the leading philanthropic funders of HIV-related programs in
a report released by Funders Concerned About AIDS.
Forward-Looking
Statements
This press release includes forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of 1995
that are subject to risks, uncertainties and other factors,
including Gilead’s ability to initiate, progress and complete
clinical trials in the anticipated timelines or at all, and the
possibility of unfavorable results from ongoing and additional
clinical trials, including those involving lenacapavir (such as
PURPOSE 1 and PURPOSE 2); uncertainties relating to regulatory
applications and related filing and approval timelines, including
the New Drug Applications seeking FDA approval and the MAA and
EU-M4all seeking EMA approval of lenacapavir for PrEP, and the risk
that any regulatory approvals, if granted, may be subject to
significant limitations on use or subject to withdrawal or other
adverse actions by the applicable regulatory authority; the
possibility that Gilead may make a strategic decision to
discontinue development of lenacapavir for indications currently
under evaluation and, as a result, lenacapavir may never be
successfully commercialized for such indications; Gilead’s ability
to effectively manage the access strategy relating to lenacapavir,
subject to necessary regulatory approvals; and any assumptions
underlying any of the foregoing. These and other risks,
uncertainties and factors are described in detail in Gilead’s
Quarterly Report on Form 10-Q for the quarter ended September 30,
2024, as filed with the U.S. Securities and Exchange Commission.
These risks, uncertainties and other factors could cause actual
results to differ materially from those referred to in the
forward-looking statements. All statements other than statements of
historical fact are statements that could be deemed forward-looking
statements. The reader is cautioned that any such forward-looking
statements are not guarantees of future performance and involve
risks and uncertainties, and is cautioned not to place undue
reliance on these forward-looking statements. All forward-looking
statements are based on information currently available to Gilead,
and Gilead assumes no obligation and disclaims any intent to update
any such forward-looking statements.
U.S. full Prescribing Information for Truvada,
including Boxed Warning, and lenacapavir are available at
www.gilead.com.
Gilead and the Gilead logo, Truvada, and
Truvada for PrEP are registered trademarks of Gilead Sciences,
Inc., or its related companies.
For more information about Gilead, please visit
the company’s website at www.gilead.com, follow Gilead on X/Twitter
(@Gilead Sciences) and LinkedIn (@Gilead-Sciences).
View source
version on businesswire.com: https://www.businesswire.com/news/home/20250223971731/en/
Ashleigh Koss, Media public_affairs@gilead.com
Jacquie Ross, Investors investor_relations@gilead.com
Gilead Sciences (NASDAQ:GILD)
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