– EMA MAA Validation Follows Submission of
NDA for Lenacapavir to the U.S. FDA –
– If Authorized, Lenacapavir Would be the
First Capsid Inhibitor and the Only HIV-1 Treatment Option
Administered Twice Yearly –
Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the
company’s Marketing Authorization Application (MAA) for
lenacapavir, an investigational, long-acting HIV-1 capsid
inhibitor, has been fully validated and is now under evaluation
with the European Medicines Agency (EMA). The proposed indication
is for the treatment of HIV-1 infection, in combination with other
antiretroviral(s), in adults with multidrug resistant HIV-1
infection who are currently on a failing antiretroviral treatment
regimen due to resistance, intolerance or safety
considerations.
The application will be reviewed by the EMA’s Committee for
Medicinal Products for Human Use (CHMP) under the centralized
licensing procedure for all 27 Member States of the European Union,
as well as Norway, Iceland and Liechtenstein.
“Lenacapavir is a breakthrough innovation that has the potential
to be transformative for people with multi-drug resistant HIV, who
have very limited treatment options,” said Merdad Parsey, MD, PhD,
Chief Medical Officer, Gilead Sciences. “The MAA validation is a
step forward in our commitment to a patient-centered approach to
helping all individuals living with HIV achieve and sustain viral
load suppression, irrespective of their prior treatment
history.”
The MAA is supported by data from the ongoing CAPELLA study,
which achieved its primary endpoint by demonstrating that a
significantly higher proportion of participants randomly allocated
to receive oral lenacapavir in combination with an optimized
background regimen (n=24) achieved a clinically meaningful viral
load reduction of at least 0.5 log10 copies/mL from baseline
compared with those randomly allocated to receive placebo (n=12)
during the 14-day functional monotherapy period (88% vs. 17%,
p<0.0001). Lenacapavir was generally well-tolerated, with no
serious adverse events related to study drug and no study drug
discontinuations through the 14-day period, including no
discontinuations due to adverse events. The most common adverse
events observed were injection site reactions. These data were
previously presented at the virtual 28th Conference on Retroviruses
and Opportunistic Infections (virtual CROI 2021). 26-week data from
the CAPELLA study were presented at the 11th International AIDS
Society (IAS) Conference on HIV Science. Additional data from the
CAPELLA study will be presented at a future scientific
conference.
In June 2021, Gilead submitted a New Drug Application (NDA) for
lenacapavir seeking U.S. Food & Drug Administration (FDA)
approval for the treatment of HIV-1 infection in heavily
treatment-experienced people with multi-drug resistant HIV-1
infection in combination with other antiretrovirals. In May 2019,
the FDA granted Breakthrough Therapy Designation for the
development of lenacapavir for the treatment of HIV-1 infection in
heavily treatment-experienced patients with multi-drug resistance
in combination with other antiretroviral drugs.
Lenacapavir is an investigational compound and is not approved
by any regulatory authority for any use; its safety and efficacy
are not established. There is no cure for HIV or AIDS.
About CAPELLA
(NCT04150068)
CAPELLA is a Phase 2/3, double-blinded, placebo-controlled
global multi-center study designed to evaluate the antiviral
activity of Gilead’s investigational, long-acting HIV-1 capsid
inhibitor lenacapavir administered every six months as a
subcutaneous injection in heavily treatment-experienced people with
multi-drug resistant HIV-1 infection. CAPELLA includes men and
women living with HIV-1 and is being conducted at research centers
in North America, Europe and Asia.
In CAPELLA, 36 participants with multi-class HIV-1 drug
resistance and a detectable viral load while on a failing regimen
were randomly allocated to receive oral lenacapavir or placebo in a
2:1 ratio for 14 days, in addition to continuing their failing
regimen (functional monotherapy). An additional 36 participants
were enrolled in a separate treatment cohort, starting oral
lenacapavir on Day 1. Both cohorts are part of the ongoing
maintenance period of the study evaluating the safety and efficacy
of subcutaneous lenacapavir administered every six months in
combination with an optimized background regimen. The primary
endpoint was the proportion of participants randomly allocated to
receive lenacapavir or placebo for 14 days, in addition to
continuing their failing regimen, achieving ≥0.5 log10 copies/mL
reduction from baseline in HIV-1 RNA at the end of the functional
monotherapy period. Following 14 days of lenacapavir oral therapy,
all participants started open-label lenacapavir, administered as a
subcutaneous injection every six months, in combination with an
optimized background regimen. This ongoing maintenance period of
the study is evaluating the additional trial endpoints of safety
and efficacy of subcutaneous lenacapavir administered every six
months in combination with an optimized background regimen.
For further information, please see
https://clinicaltrials.gov/ct2/show/NCT04150068.
About Lenacapavir
Lenacapavir is a potential first-in-class, long-acting HIV-1
capsid inhibitor in development for the treatment of HIV-1
infection. The safety and efficacy of 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 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.
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 more than 30 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 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 or complete
clinical trials or studies involving lenacapavir within currently
anticipated timelines or at all; the possibility of unfavorable
results from ongoing or additional clinical trials or studies
involving lenacapavir; Gilead’s ability to receive regulatory
approvals in a timely manner or at all, including EMA approval of
lenacapavir for the treatment of HIV-1 infection, in combination
with other antiretroviral(s), in adults with multidrug resistant
HIV-1 infection who are currently on a failing antiretroviral
treatment regimen due to resistance, intolerance or safety
considerations, or FDA approval of lenacapavir for the treatment of
HIV-1 infection in heavily treatment-experienced people with
multi-drug resistant HIV-1 infection, and the risk that any such
approvals may be subject to significant limitations on use; the
possibility that Gilead may make a strategic decision to
discontinue development of lenacapavir and that, 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 June 30, 2021,
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 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.
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