– If Approved, Lenacapavir Would Be the
First and Only Twice-Yearly HIV Prevention Choice –
– FDA to Review Applications Under Priority
Review, with a PDUFA Date of June 19, 2025 –
– Gilead Also Recently Submitted
Applications for Lenacapavir for PrEP to the European Medicines
Agency That Will Be Reviewed Under Accelerated Assessment Review
Timeline –
Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the
U.S. Food and Drug Administration (FDA) has accepted its New Drug
Application (NDA) submissions for lenacapavir—the company’s
twice-yearly injectable HIV-1 capsid inhibitor—for the prevention
of HIV as pre-exposure prophylaxis (PrEP).
The FDA will review the applications under priority review and
has assigned a Prescription Drug User Fee Act (PDUFA) target action
date of June 19, 2025. Acceptance of the NDAs follows receipt of
Breakthrough Therapy Designation for lenacapavir for PrEP granted
by the FDA in October 2024. The Breakthrough Therapy Designation
process is intended to expedite the development and regulatory
review of investigational treatments for serious or
life-threatening conditions that, based on preliminary clinical
evidence, have the potential to substantially improve clinical
outcomes compared with available therapy.
“Today, we are one step closer to introducing the first-ever
twice-yearly HIV prevention choice that could, if approved, help
transform the landscape for individuals who need or want additional
prevention options that better fit into their lives,” said Dietmar
Berger, MD, PhD, Chief Medical Officer, Gilead Sciences. “We’re
excited about the potential of lenacapavir to make a real
difference in HIV prevention in the U.S. and around the world,
supporting the broader goal of ending the HIV epidemic for
everyone, everywhere.”
The NDAs are based on 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. As part of that strategy, earlier this year Gilead
submitted a European Commission marketing authorization application
(MAA) and an EU-Medicines for All (EU-M4all) application to the
European Medicines Agency (EMA) for lenacapavir for PrEP. The
EU-M4all application aims to help facilitate availability of
lenacapavir for PrEP in low- and lower-middle-income countries.
Through the EU-M4all procedure, national regulatory authorities in
these regions can leverage the EU opinion to expedite their review
processes, potentially accelerating access to lenacapavir for
PrEP.
Updates on regulatory filings for lenacapavir for PrEP will be
shared as discussions with regulatory bodies progress.
The use of lenacapavir for the prevention of HIV is
investigational and is not approved anywhere globally. The safety
and efficacy of this use has not been established by the U.S.
FDA.
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/20250217805274/en/
Ashleigh Koss, Media public_affairs@gilead.com
Jacquie Ross, Investors investor_relations@gilead.com
Gilead Sciences (NASDAQ:GILD)
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