Gilead Resubmits New Drug Application to U.S. Food and Drug Administration for Lenacapavir, an Investigational, Long-Acting HIV-1 Capsid Inhibitor
June 27 2022 - 4:30PM
Business Wire
– NDA Resubmission Addresses Issues Related
to Vial Compatibility –
– If Approved, Lenacapavir Would be the
First and the Only HIV-1 Treatment Option Administered
Twice-Yearly –
Gilead Sciences, Inc. (Nasdaq: GILD) today announced the
resubmission of the New Drug Application (NDA) to the U.S. Food and
Drug Administration (FDA) for lenacapavir, an investigational,
long-acting HIV-1 capsid inhibitor, for the treatment of HIV-1
infection in heavily treatment-experienced (HTE) people with
multi-drug resistant (MDR) HIV-1 infection.
Gilead resubmitted the NDA in response to the FDA Complete
Response Letter (CRL) issued in February 2022, which cited
Chemistry Manufacturing and Controls (CMC) issues relating to the
compatibility of lenacapavir in borosilicate vials as the reason
for the FDA action. The NDA resubmission contains comprehensive CMC
data to support the compatibility of lenacapavir with an
alternative vial type made from aluminosilicate glass. In addition,
the NDA is supported by extensive pre-clinical and earlier clinical
research data as well as data from the Phase 2/3 CAPELLA study,
which evaluated the antiviral activity of lenacapavir administered
every six months as a subcutaneous injection, in combination with
other antiretroviral(s), in heavily treatment-experienced people
with multi-drug resistant HIV-1 infection.
Once accepted by the FDA, a new Prescription Drug User Fee Act
(PDUFA) date will be established.
"There are people with HIV who have severely limited treatment
options due to resistance to multiple antiretroviral therapy
classes," said Jared Baeten, MD, PhD, Vice President, HIV Clinical
Development, Gilead Sciences. "We are committed to addressing unmet
needs and recognize the urgency for filling the critical treatment
gap for people with multi-drug resistant HIV whose virus is no
longer effectively responding to their current therapy."
Lenacapavir is an investigational compound and is not approved
by any regulatory authority for any use and its safety and efficacy
are not established. There is no cure for HIV or AIDS.
About Lenacapavir
Lenacapavir is Gilead’s potential first-in-class,
investigational long-acting HIV-1 capsid inhibitor in development
for the treatment of HIV-1 infection. The safety, efficacy and
dosing of Gilead’s investigational, long-acting HIV-1 capsid
inhibitor lenacapavir are being evaluated in multiple ongoing
clinical studies. Lenacapavir's multi-stage mechanism of action is
distinguishable from currently approved classes of antiviral agents
and is designed to provide a new avenue for the development of
long-acting therapy options for people living with or at risk for
HIV-1. While most antivirals act on just one stage of viral
replication, lenacapavir is designed to inhibit HIV-1 at multiple
stages of its lifecycle and has no known cross resistance to other
existing drug classes. If approved, lenacapavir would be the only
HIV-1 treatment option administered twice-yearly.
About Gilead Sciences
Gilead Sciences, Inc. is a biopharmaceutical company that has
pursued and achieved breakthroughs in medicine for more than three
decades, with the goal of creating a healthier world for all
people. The company is committed to advancing innovative medicines
to prevent and treat life-threatening diseases, including HIV,
viral hepatitis and cancer.
For 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 11 HIV medications,
including the first single-tablet regimen to treat HIV and the
first antiretroviral for pre-exposure prophylaxis (PrEP) to reduce
the risk of acquiring HIV infection. These advances in medical
research have helped to transform HIV into a 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 and collaborations, 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 the number one
philanthropic funder of HIV-related programs in a report released
by Funders Concerned About AIDS.
Gilead operates in more than 35 countries worldwide, with
headquarters in Foster City, California.
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 involving lenacapavir in the anticipated timelines
or at all; the possibility of unfavorable results from ongoing and
additional clinical trials involving lenacapavir; uncertainties
relating to regulatory applications and related filing and approval
timelines, including the risk that the FDA may not approve the NDA
for lenacapavir for the treatment of HIV-1 infection in HTE people
with MDR HIV-1 infection in a timely manner or at all; the risk
that any regulatory approvals, if granted, may be subject to
significant limitations on use; the possibility that Gilead may
make a strategic decision to discontinue development of lenacapavir
and as a result, lenacapavir may never be successfully
commercialized; 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 March 31, 2022, 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.
GILEAD and the GILEAD logo are trademarks of
Gilead Sciences, Inc. All other trademarks are the property of
their respective owners.
For more information about Gilead, please visit
the company’s website at www.gilead.com, follow Gilead on Twitter
(@Gilead Sciences) or call Gilead Public Affairs at 1-800-GILEAD-5
or 1-650-574-3000.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20220627005599/en/
Jacquie Ross, Investors investor_relations@gilead.com
Brian Plummer, Media brian.plummer@gilead.com
Gilead Sciences (NASDAQ:GILD)
Historical Stock Chart
From Aug 2024 to Sep 2024
Gilead Sciences (NASDAQ:GILD)
Historical Stock Chart
From Sep 2023 to Sep 2024