Breakthrough Designation awarded following empagliflozin’s results in first and only successful trial for HFpEF
INGELHEIM, Germany & INDIANAPOLIS-Thursday 9 September 2021 [ AETOS Wire ]
(BUSINESS
WIRE)-- The U.S. Food and Drug Administration (FDA) has granted
Breakthrough Therapy Designation for empagliflozin as an investigational
treatment for adults with heart failure with preserved ejection
fraction (HFpEF), Boehringer Ingelheim and Eli Lilly and Company (NYSE:
LLY) announced. This follows results from the Phase III
EMPEROR-Preserved trial which investigated the composite endpoint of
cardiovascular death or hospitalization for heart failure in patients
with HFpEF.1
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210909005550/en/
“We
are pleased that the FDA has recognized empagliflozin as a Breakthrough
Therapy so soon after the publication of the EMPEROR-Preserved clinical
trial results in HFpEF,” commented Ivan Blanarik, Head of Therapeutic
Area CardioMetabolism & Respiratory, Boehringer Ingelheim.
“Breakthrough Therapy Designation is testament to our commitment to the
goal of improving outcomes for people affected by diseases across the
cardio-renal-metabolic spectrum.”
HFpEF has been described as the
single largest unmet need in cardiovascular medicine based on
prevalence, poor outcomes and the previous absence of clinically proven
therapies.2,3 A leading cause of hospitalization in the U.S. and Europe,
its prevalence is increasing and is estimated to affect approximately
30 million people worldwide – about half of all cases of heart
failure.4,5
Breakthrough designation is given to treatments of
serious or life-threatening conditions where preliminary evidence
indicates that the drug may demonstrate substantial improvement on
clinically significant endpoints compared to existing therapies.
The
EMPEROR-Preserved Phase III trial results were presented during a
hotline session of the European Society of Cardiology (ESC) Congress
2021 and simultaneously published in The New England Journal of
Medicine.
Empagliflozin is currently indicated for the treatment
of adults with insufficiently controlled type 2 diabetes.6,7,8
Additionally, empagliflozin is approved for the treatment of adults with
heart failure with reduced ejection fraction (HFrEF), with or without
diabetes, in the European Union and the U.S.6,9 Boehringer Ingelheim and
Lilly Alliance plan for global regulatory submissions in HFpEF in 2021.
# Ends #
About the EMPEROR heart failure studies10,11
The
EMPEROR (EMPagliflozin outcomE tRial in patients with chrOnic heaRt
failure) chronic heart failure studies were two Phase III, randomized,
double-blind trials that investigated once-daily empagliflozin compared
to placebo in adults with chronic HFrEF or HFpEF, with or without
diabetes:
EMPEROR-Reduced [NCT03057977] investigated the safety and efficacy of empagliflozin in patients with chronic HFrEF.
Primary endpoint: time to first event of adjudicated cardiovascular death or adjudicated hospitalization for heart failure
Number of patients: 3,730
Completion: 2020
EMPEROR-Preserved [NCT03057951] investigated the safety and efficacy of empagliflozin in patients with chronic HFpEF.
Primary endpoint: time to first event of adjudicated cardiovascular death or adjudicated hospitalization for heart failure
Number of patients: 5,988
Completion: 2021
About the EMPOWER program
The
Boehringer Ingelheim and Lilly Alliance has developed the EMPOWER
program to explore the impact of empagliflozin on major clinical
cardiovascular and renal outcomes in a spectrum of
cardio-renal-metabolic conditions. Cardio-renal-metabolic conditions are
the leading cause of mortality worldwide and account for up to 20
million deaths annually.12 Through the EMPOWER program, the Alliance is
working to advance knowledge of these interconnected systems and create
care which offers integrated, multi-organ benefits. Comprised of nine
clinical trials and two real-world evidence studies, EMPOWER reinforces
the long-term commitment of the Alliance to improve outcomes for people
living with cardio-renal-metabolic conditions. With more than 400,000
adults enrolled worldwide in clinical studies, it is one of the broadest
and most comprehensive clinical programs for an SGLT2 inhibitor to
date.
About heart failure
Heart failure is a progressive,
debilitating and potentially fatal condition that occurs when the heart
cannot supply adequate circulation to meet the body’s demands for
oxygenated blood.13 To do so, it requires increased blood volume leading
to fluid accumulation (congestion) in the lungs and peripheral
tissues.14 It is a common condition affecting over 60 million people
worldwide and expected to increase as the population ages.4,5 Heart
failure is highly prevalent in people with diabetes; 15 however, more
than half of all people with heart failure do not have diabetes.16
There
are different types of heart failure. People with left-sided heart
failure have either a reduced or a preserved ejection fraction. Ejection
fraction is a measurement of the percentage of blood the left ventricle
pumps out with each contraction.17 When the heart relaxes, the
ventricle refills with blood.
Heart failure with preserved
ejection fraction occurs when the left ventricle of the heart is unable
to relax and properly fill with blood, resulting in less blood being
available to be pumped out to the body.17
Heart failure with
reduced ejection fraction occurs when the left ventricle of the heart is
not able to contract effectively, which means that the heart cannot
pump with enough force, so less blood is pushed out to the body.17
People
with heart failure often experience breathlessness and fatigue, which
can severely impact their quality of life.18 Individuals with heart
failure often also have impaired kidney function, which can have a
significant negative impact on prognosis.19
About cardio-renal-metabolic conditions
Boehringer
Ingelheim and Lilly are driven to transform care for people with
cardio-renal-metabolic conditions, a group of interconnected disorders
that affect more than one billion people worldwide and are a leading
cause of death.5,12
The cardiovascular, renal and metabolic
systems are interconnected, and share many of the same risk factors and
pathological pathways along the disease continuum. Dysfunction in one
system may accelerate the onset of others, resulting in progression of
interconnected diseases such as type 2 diabetes, cardiovascular disease,
heart failure, and kidney disease, which in turn leads to an increased
risk of cardiovascular death. Conversely, improvements in one system can
lead to positive effects throughout the others.20,21,22
Through
our research and treatments, our goal is to support people’s health,
restoring the balance between the interconnected cardio-renal-metabolic
systems and reducing their risk of serious complications. As part of our
commitment to those whose health is jeopardized by
cardio-renal-metabolic conditions, we will continue embracing a
multidisciplinary approach towards care and focusing our resources on
filling treatment gaps.
About empagliflozin
Empagliflozin
(marketed as Jardiance®) is an oral, once-daily, highly selective
sodium-glucose cotransporter 2 (SGLT2) inhibitor and the first type 2
diabetes medicine to include cardiovascular death risk reduction data in
its label in several countries.6,7,8
Please click on the
following link for ‘Notes to Editors’ and ‘References’
http://www.boehringer-ingelheim.com/press-release/fda-hfpef-breakthrough-designation-emperor-preserved
View source version on businesswire.com: https://www.businesswire.com/news/home/20210909005550/en/
Contacts
Stefanie Molkenthin
Product Communication Manager
Boehringer Ingelheim
Email: press@boehringer-ingelheim.com
Phone: +49 (6132) 77 172 209
Anna Bergmann
Global Business Communications
Eli Lilly and Company
Email: anna.bergmann@lilly.com
Phone: +1 317 864 3143
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