THOUSAND OAKS, Calif.,
March 28, 2020 /PRNewswire/
-- Amgen (NASDAQ:AMGN) today announced positive results from
the EvolocumaB Effect on LDL-C LowerIng in SubJEcts with Human
Immunodeficiency ViRus and INcreased Cardiovascular RisK
(BEIJERINCK) study evaluating the efficacy and safety of
Repatha® (evolocumab) in patients who are human
immunodeficiency virus-positive (HIV+) and have high low-density
lipoprotein cholesterol (LDL-C) despite stable background
lipid-lowering therapy.1 The study demonstrated that
treatment with Repatha significantly reduced LDL-C. The results
were featured as an oral presentation during the virtual American
College of Cardiology's 69th Annual Scientific Session
from March 28-30, 2020 with
publication in the Journal of the American College of Cardiology
(JACC) on March 30, 2020.
"Certain antiretroviral treatments for HIV can increase LDL-C
and change the lipid makeup of people living with HIV. This study
increases our overall evidence base for Repatha, but also provides
us with a better understanding of cholesterol management for this
under-represented patient population," said David M. Reese, M.D., executive vice president
of Research and Development at Amgen. "These positive results show
that Repatha can help these patients lower their LDL-C, one of the
most important modifiable risk factors for cardiovascular
disease."
Results from the double-blind 24-week study show that in people
living with HIV (PLHIV) with hypercholesterolemia or mixed
dyslipidemia, monthly treatment with Repatha reduced LDL-C by 56.9%
from baseline compared to placebo, meeting its primary
endpoint.1 Patients treated with Repatha also
demonstrated improved secondary outcomes versus placebo with 71.9%
of patients achieving an LDL-C reduction of more than or equal to
50% from baseline and 65.4% of patients achieving an LDL-C of less
than 70 mg/dL.1 No new safety concerns were identified
in the BEIJERINCK trial.1 The subject incidence of
treatment-emergent adverse events was comparable among both
groups.1
"Professional guidelines, including most recently those from the
European Society of Cardiology and the European Atherosclerosis
Society, have called for greater research into the efficacy and
safety of PCSK9 inhibitors in specific populations, like people
living with HIV. The American Heart Association and American
College of Cardiology multi-society cholesterol guidelines also
identify HIV infection as a cardiovascular risk-enhancing factor,"
said Professor Franck Boccara, M.D., PhD, cardiologist and primary
study investigator, Sorbonne Université, Paris. "This is the first Phase 3 study to
demonstrate that a PCSK9 inhibitor can effectively and safely
reduce LDL-C in people living with HIV at risk for cardiovascular
disease who have high cholesterol level despite statin treatment.
Addressing uncontrolled LDL-C in this high-risk patient population
is critical to maintain the progress that has been achieved in
improving the lives of people living with HIV."
Approximately 38 million individuals live with HIV worldwide,
with 1.1 million in the United
States.2,3 Cardiovascular (CV) risk is estimated
to be nearly double in PLHIV compared to individuals who don't have
HIV, and PLHIV face significant health challenges at earlier ages
than people who don't have HIV.4 The global burden of
HIV-associated cardiovascular disease has tripled over the past two
decades, and it will continue to increase as the population of
individuals living with HIV ages.5 Today, 75
percent of PLHIV are over age 45.6
The Phase 3b BEIJERINCK study is
part of Amgen's PROFICIO (Program to Reduce LDL-C and
cardiovascular Outcomes Following Inhibition of
PCSK9 In different pOpulations) program of clinical and
real-world evidence (RWE) studies investigating the impact of
Repatha and examining the use of lipid-lowering therapies across
different patient populations. To date,
the PROFICIO program consists of 35 clinical trials
including more than 41,000 patients worldwide and more than 80
real-world evidence studies.
About BEIJERINCK Study Design
EvolocumaB Effect on
LDL-C LowerIng in SubJEcts with Human Immunodeficiency ViRus and
INcreased Cardiovascular RisK (BEIJERINCK) is a double-blind,
randomized, placebo-controlled study designed to evaluate the
efficacy and safety of 420 mg once-monthly treatment with
evolocumab in HIV+ patients with hyperlipidemia or mixed
dyslipidemia over 24 weeks. The study enrolled 467 adults with
known HIV infection who have received stable HIV therapy for six
months or more prior to randomization and have also been treated
with maximally tolerated lipid-lowering therapy for four weeks or
longer prior to randomization. Both background therapies were not
expected to change during the duration of study participation.
Statin-intolerant patients were also eligible for the study.
Evolocumab-treated patients who completed the 24-week double-blind
treatment period were enrolled in an open-label period through the
end of the study at week 52.
About Repatha® (evolocumab)
Repatha is
a human monoclonal antibody that inhibits proprotein convertase
subtilisin/kexin type 9 (PCSK9). Repatha binds to PCSK9 and
inhibits circulating PCSK9 from binding to the low-density
lipoprotein (LDL) receptor (LDLR), preventing PCSK9-mediated LDLR
degradation and permitting LDLR to recycle back to the liver cell
surface. By inhibiting the binding of PCSK9 to LDLR, Repatha
increases the number of LDLRs available to clear LDL from the
blood, thereby lowering LDL-C levels.7
Repatha is approved in more than 70 countries, including the
U.S., Japan, Canada and in all 28 countries that are
members of the European Union. Applications in other countries
are pending.
Important U.S. Product Information
Repatha is a PCSK9 (proprotein convertase subtilisin/kexin type
9) inhibitor antibody indicated:
- to reduce the risk of myocardial infarction, stroke, and
coronary revascularization in adults with established
cardiovascular disease.
- as an adjunct to diet, alone or in combination with other
lipid-lowering therapies (e.g., statins, ezetimibe), for treatment
of adults with primary hyperlipidemia (including heterozygous
familial hypercholesterolemia [HeFH]) to reduce low-density
lipoprotein cholesterol (LDL-C).
- as an adjunct to diet and other LDL-lowering therapies (e.g.,
statins, ezetimibe, LDL apheresis) in patients with homozygous
familial hypercholesterolemia (HoFH) who require additional
lowering of LDL-C.
The safety and effectiveness of Repatha have not been
established in pediatric patients with HoFH who are younger than 13
years old or in pediatric patients with primary hyperlipidemia or
HeFH.
Important U.S. Safety Information
Contraindication: Repatha is contraindicated in
patients with a history of a serious hypersensitivity reaction to
Repatha. Serious hypersensitivity reactions including angioedema
have occurred in patients treated with Repatha.
Allergic reactions: Hypersensitivity reactions (e.g.
angioedema, rash, urticaria) have been reported in patients treated
with Repatha, including some that led to discontinuation of
therapy. If signs or symptoms of serious allergic reactions occur,
discontinue treatment with Repatha, treat according to the standard
of care, and monitor until signs and symptoms resolve.
Adverse reactions: The most common adverse reactions
(>5% of patients treated with Repatha and occurring more
frequently than placebo) were: nasopharyngitis, upper respiratory
tract infection, influenza, back pain, and injection site
reactions.
From a pool of the 52-week trial and seven 12-week trials: Local
injection site reactions occurred in 3.2% and 3.0% of
Repatha-treated and placebo-treated patients, respectively. The
most common injection site reactions were erythema, pain, and
bruising.
Allergic reactions occurred in 5.1% and 4.7% of Repatha-treated
and placebo-treated patients, respectively. The most common
allergic reactions were rash (1.0% versus 0.5% for Repatha and
placebo, respectively), eczema (0.4% versus 0.2%), erythema (0.4%
versus 0.2%), and urticaria (0.4% versus 0.1%).
The most common adverse reactions in the Cardiovascular Outcomes
Trial (>5% of patients treated with Repatha and occurring more
frequently than placebo) were: diabetes mellitus (8.8% Repatha,
8.2% placebo), nasopharyngitis (7.8% Repatha, 7.4% placebo), and
upper respiratory tract infection (5.1% Repatha, 4.8%
placebo).
Among the 16,676 patients without diabetes mellitus at baseline,
the incidence of new-onset diabetes mellitus during the trial was
8.1% in patients assigned to Repatha compared with 7.7% in those
assigned to placebo.
Homozygous Familial Hypercholesterolemia (HoFH): The
adverse reactions that occurred in at least two patients treated
with Repatha and more frequently than placebo were: upper
respiratory tract infection, influenza, gastroenteritis, and
nasopharyngitis.
Immunogenicity: Repatha is a human monoclonal
antibody. As with all therapeutic proteins, there is a potential
for immunogenicity with Repatha.
Please contact Amgen Medinfo at 800-77-AMGEN (800-772-6436)
or 844-REPATHA (844-737-2842) regarding
Repatha® availability or find more information,
including full Prescribing Information,
at www.amgen.com and www.Repatha.com.
About Amgen in the Cardiovascular Therapeutic
Area
Building on more than three decades of experience in
developing biotechnology medicines for patients with serious
illnesses, Amgen is dedicated to addressing important
scientific questions to advance care and improve the lives of
patients with cardiovascular disease, the leading cause of
morbidity and mortality worldwide. Amgen's research into
cardiovascular disease, and potential treatment options, is part of
a growing competency at Amgen that utilizes human
genetics to identify and validate certain drug targets. Through its
own research and development efforts, as well as
partnerships, Amgen is building a robust cardiovascular
portfolio consisting of several approved and investigational
molecules in an effort to address a number of today's important
unmet patient needs, such as high cholesterol and heart
failure.
About Amgen
Amgen is committed to unlocking the
potential of biology for patients suffering from serious illnesses
by discovering, developing, manufacturing and delivering innovative
human therapeutics. This approach begins by using tools like
advanced human genetics to unravel the complexities of disease and
understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages
its biologics manufacturing expertise to strive for solutions that
improve health outcomes and dramatically improve people's lives. A
biotechnology pioneer since 1980, Amgen has grown to be the world's
largest independent biotechnology company, has reached millions of
patients around the world and is developing a pipeline of medicines
with breakaway potential.
For more information, visit www.amgen.com and follow us on
www.twitter.com/amgen.
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CONTACT: Amgen, Thousand
Oaks
Trish Rowland, 805-447-5631
(Media)
Jessica Akopyan, 805-447-0974
(Media)
Megan Fox, 805-447-1423 (Media)
Arvind Sood, 805-447-1060
(Investors)
References
- Bocarra F., et al. Evolocumab Use in Patients With Human
Immunodeficiency Virus and Dyslipidemia: Primary Results of a
Double-Blind, Placebo-Controlled Study (BEIJERINCK). To be
presented at ACC Scientific Sessions, Abstract Number 913-08
(2020).
- World Health Organization. HIV/AIDS. Available at:
https://www.who.int/gho/hiv/en/. Accessed February 2020.
- Centers for Disease Control and Prevention. HIV Surveillance
Report, 2018 (Preliminary); vol. 30. Available at:
http://www.cdc.gov/hiv/library/reports/hiv-surveillance.html.
Accessed February 2020.
- Centers for Disease Control and Prevention. Estimated HIV
incidence and prevalence in the United
States, 2010–2016. HIV Surveillance Supplemental Report
2019;24(No. 1). Available at:
http://www.cdc.gov/hiv/library/reports/hiv-surveillance.html.
Accessed February 2020.
- Shah AS., et al. Global Burden of Atherosclerotic
Cardiovascular Disease in People Living With HIV. Circulation.
2018;138:1100–1112.
- American Heart Association. People living with HIV face
premature heart disease and barriers to care. Available at:
https://newsroom.heart.org/news/people-living-with-hiv-face-premature-heart-disease-and-barriers-to-care.
Accessed February 2020.
- Repatha Prescribing Information; Amgen, Thousand Oaks, CA, 2018.
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