RIDGEFIELD, Conn. and INDIANAPOLIS, Sept. 15, 2020 /PRNewswire/ -- The U.S. Food
and Drug Administration (FDA) has granted Fast Track designation
for the development of Jardiance® (empagliflozin) to prevent
hospitalization for heart failure and reduce the risk of mortality
in patients, with and without diabetes, who have had an acute
myocardial infarction (more commonly known as a heart attack),
Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY)
announced. More than 1.5 million heart attacks, which are the
leading cause of heart failure and are associated with a high risk
of death, occur annually in the U.S. A heart attack occurs as
a result of reduced blood flow to part of the heart muscle.
"Ischemic heart disease (IHD) is the leading cause of death and
disability in the U.S. Myocardial infarction, or heart attack, is
the deadliest acute manifestation of IHD, and treatment options are
urgently needed to help improve outcomes," said Mohamed Eid, M.D., M.P.H., M.H.A., vice
president, Clinical Development & Medical Affairs,
Cardio-Metabolism & Respiratory Medicine, Boehringer Ingelheim
Pharmaceuticals, Inc. "We look forward to working closely with the
FDA as we explore the potential for Jardiance to improve survival
and prevent hospitalization for heart failure for adults who have
had a heart attack, through our EMPACT-MI trial."
EMPACT-MI (A Streamlined, Multicenter, Randomized, Parallel
Group, Double-blind Placebo-controlled Superiority Trial to
Evaluate the Effect of EMPAgliflozin on Hospitalization for Heart
Failure and Mortality in Patients With aCuTe Myocardial Infarction)
is investigating the effect of Jardiance on all-cause mortality and
hospitalization for heart failure in adults with and without type 2
diabetes who have had an acute myocardial infarction and no history
of chronic heart failure. This randomized clinical phase III trial
is being conducted, analyzed and reported in partnership with the
Duke Clinical Research Institute (DCRI), with Boehringer Ingelheim
and Lilly providing funding. EMPACT-MI is part of the EMPOWER
clinical program, the broadest and most comprehensive clinical
program for an SGLT2 inhibitor. EMPOWER explores the impact of
Jardiance on the lives of people across the spectrum of
cardio-renal-metabolic conditions.
Jardiance is a once-daily tablet used along with diet and
exercise to lower blood sugar in adults with type 2 diabetes and to
reduce the risk of cardiovascular death in adults with type 2
diabetes and known cardiovascular disease. Jardiance is
contraindicated in patients with a history of serious
hypersensitivity reaction to empagliflozin or any of the excipients
of Jardiance, and in patients with severe renal impairment,
end-stage renal disease, or dialysis. Jardiance is not for people
with type 1 diabetes or for people with diabetic ketoacidosis
(increased ketones in the blood or urine).
"The FDA Fast Track designation for Jardiance is an important
milestone towards addressing an unmet need for people who have had
a heart attack," said Jeff Emmick,
M.D., Ph.D., vice president, Product Development, Lilly. "We remain
committed to finding breakthrough outcomes for people with and
without type 2 diabetes, including the prevention and treatment of
heart failure. We look forward to learning the results of
EMPACT-MI, which are anticipated in 2023."
About the EMPOWER program
The Alliance has developed
the EMPOWER program to explore the impact of Jardiance 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. Through the EMPOWER program,
Boehringer Ingelheim and Lilly are working to advance knowledge of
these interconnected systems and create care which offers
integrated, multi-organ benefits. Comprised of eight 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
257,000 adults studied worldwide in clinical studies, it is the
broadest and most comprehensive clinical program for an SGLT2
inhibitor to date.
The development program encompasses:
- EMPEROR-Reduced, in adults with chronic heart failure with
reduced ejection fraction to reduce the risk of cardiovascular
death or hospitalization due to heart failure
- EMPEROR-Preserved, in adults with chronic heart failure with
preserved ejection fraction to reduce the risk of cardiovascular
death or hospitalization due to heart failure
- EMPULSE, in adults hospitalized for acute heart failure and
stabilized to improve clinical and patient reported outcomes
- EMPACT-MI, to evaluate all-cause mortality and hospitalization
for heart failure in adults with and without type 2 diabetes who
have had an acute myocardial infarction, with the aim to prevent
heart failure and improve outcomes
- EMPA-KIDNEY, in adults with established chronic kidney disease
to reduce the progression of kidney disease and the occurrence of
cardiovascular death
- EMPERIAL-Reduced, in adults with chronic heart failure with
reduced ejection fraction to evaluate functional ability and
patient-reported outcomes
- EMPERIAL-Preserved, in adults with chronic heart failure with
preserved ejection fraction to evaluate functional ability and
patient-reported outcomes
- EMPA-REG OUTCOME®, in adults with type 2 diabetes and
established cardiovascular disease to reduce the risk of major
adverse cardiovascular events, including cardiovascular death
- EMPRISE, a non-interventional study of the effectiveness,
safety, healthcare utilization and cost of care of empagliflozin in
routine clinical practice in adults with type 2 diabetes across the
cardiovascular risk continuum
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.
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, improving the health of one system can lead to positive
effects throughout the others.
Through our research and treatments, our goal is to support
people's health, restoring the harmony 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.
What is JARDIANCE? (www.jardiance.com)
JARDIANCE is a prescription medicine used
along with diet and exercise to lower blood
sugar in adults with type 2 diabetes.
JARDIANCE is also used to reduce the risk of cardiovascular
death in adults with type 2 diabetes who have known cardiovascular
disease.
JARDIANCE is not for people with type 1
diabetes or for people with diabetic
ketoacidosis (increased ketones in the blood or
urine).
IMPORTANT SAFETY INFORMATION
Do not take
JARDIANCE if you are allergic to
empagliflozin or any of the ingredients in
JARDIANCE.
Do not take JARDIANCE if you have severe
kidney problems or are on dialysis.
JARDIANCE can cause serious side effects, including:
- Dehydration. JARDIANCE can cause some people to have
dehydration (the loss of body water and salt). Dehydration may
cause you to feel dizzy, faint, light-headed, or weak, especially
when you stand up.
You may be at a higher risk of dehydration if you:
-
- have low blood pressure
- take medicines to lower your blood pressure, including water
pills (diuretics)
- are on a low salt diet
- have kidney problems
- are 65 years of age or older.
- Vaginal yeast infection. Women who take JARDIANCE
may get vaginal yeast infections. Talk to your doctor if you
experience vaginal odor, white or yellowish vaginal discharge
(discharge may be lumpy or look like cottage cheese), and/or
vaginal itching.
- Yeast infection of the penis. Men who take
JARDIANCE may get a yeast infection of the skin around the penis,
especially uncircumcised males and those with chronic infections.
Talk to your doctor if you experience redness, itching or swelling
of the penis, rash of the penis, foul smelling discharge from the
penis, and/or pain in the skin around penis.
- Ketoacidosis (increased ketones in your blood or urine).
Ketoacidosis is a serious condition and may need to be treated in
the hospital. Ketoacidosis may lead to death. Ketoacidosis occurs
in people with type 1 diabetes and can also occur in people with
type 2 diabetes taking JARDIANCE, even if blood sugar is less than
250 mg/dL. Ketoacidosis has also happened in people with diabetes
who were sick or who had surgery during treatment with JARDIANCE.
Stop taking JARDIANCE and call your doctor right away if you get
any of the following symptoms, and if possible, check for
ketones in your urine:
-
-
nausea
- vomiting
- stomach-area (abdominal) pain
- tiredness
- trouble breathing
- Kidney problems. Sudden kidney injury has happened in
people taking JARDIANCE. Talk to your doctor right away if you
reduce the amount you eat or drink, or if you lose liquids; for
example, from vomiting, diarrhea, or being in the sun too
long.
- Serious urinary tract infections. Serious urinary tract
infections can occur in people taking JARDIANCE and may lead to
hospitalization. Tell your doctor if you have symptoms of a urinary
tract infection, such as a burning feeling when passing urine, a
need to urinate often or right away, pain in the lower part of your
stomach or pelvis, or blood in the urine. Sometimes people also may
have a fever, back pain, nausea or vomiting.
- Low blood sugar (hypoglycemia): If you take JARDIANCE with
another medicine that can cause low blood sugar, such as
sulfonylurea or insulin, your risk of low blood sugar is higher.
The dose of your sulfonylurea or insulin may need to be lowered.
Symptoms of low blood sugar may include:
-
- headache
- drowsiness
- weakness
- dizziness
- confusion
- irritability
- hunger
- fast heartbeat
- sweating
- shaking or feeling jittery
- Necrotizing fasciitis. A rare but serious bacterial
infection that causes damage to the tissue under the skin in the
area between and around your anus and genitals (perineum). This
bacterial infection has happened in women and men who take
JARDIANCE, and may lead to hospitalization, multiple surgeries, and
death. Seek medical attention immediately if you have fever or
are feeling very weak, tired or uncomfortable (malaise), and you
develop any of the following symptoms in the area between and
around your anus and genitals: pain or tenderness, swelling, and
redness of skin (erythema).
- Allergic (hypersensitivity) reactions. Symptoms of
serious allergic reactions to JARDIANCE may include:
-
- swelling of your face, lips, throat and other areas of your
skin
- difficulty with swallowing or breathing
- raised, red areas on your skin (hives)
If you have any of these symptoms, stop taking JARDIANCE and
contact your doctor or go to the nearest emergency room right
away.
- Increased fats in your blood (cholesterol).
The most common side effects of JARDIANCE include urinary tract infections and yeast infections in
females.
These are not all the possible side effects of JARDIANCE. For more information, ask your doctor or pharmacist.
Before taking JARDIANCE,
tell your doctor if you:
- have kidney problems. Your doctor may do blood tests to check
your kidneys before and during your treatment with JARDIANCE
- have liver problems
- have a history of urinary tract infections or problems with
urination
- are going to have surgery. Your doctor may stop your JARDIANCE
before you have surgery. Talk to your doctor if you are having
surgery about when to stop taking JARDIANCE and when to start it
again
- are eating less or there is a change in your diet
- have or have had problems with your pancreas, including
pancreatitis or surgery on your pancreas
- drink alcohol very often, or drink a lot of alcohol in the
short term ("binge" drinking)
- have any other medical conditions
- are pregnant or plan to become pregnant. JARDIANCE may harm
your unborn baby. Tell your doctor right away if you become
pregnant during treatment with JARDIANCE
- are breastfeeding or are planning to breastfeed. JARDIANCE may
pass into your breast milk and may harm your baby. Do not
breastfeed while taking JARDIANCE
Tell your doctor about all the
medicines you take, including prescription and
over-the-counter medicines, vitamins, and herbal
supplements. Especially tell
your doctor if you take water pills
(diuretics) or medicines that can lower your blood sugar, such
as insulin.
You are
encouraged to report negative side
effects of prescription drugs
to the FDA. Visit
www.fda.gov/medwatch or call 1-800-FDA-1088.
For more information, please see Prescribing Information and
Medication Guide.
CL-JAR-100057 01.27.2020
Boehringer Ingelheim and Eli Lilly and Company
In
January 2011, Boehringer Ingelheim
and Eli Lilly and Company announced an alliance that centers on
compounds representing several of the largest diabetes treatment
classes. Depending on geographies, the companies either co-promote
or separately promote the respective molecules each contributing to
the alliance. The alliance leverages the strengths of two of the
world's leading pharmaceutical companies to focus on patient needs.
By joining forces, the companies demonstrate their commitment, not
only to the care of people with diabetes, but also to investigating
the potential to address areas of unmet medical need. Clinical
trials have been initiated to evaluate the impact of Jardiance on
people living with heart failure or chronic kidney disease.
About Boehringer Ingelheim
Making new and better
medicines for humans and animals is at the heart of what we do. Our
mission is to create breakthrough therapies that change lives.
Since its founding in 1885, Boehringer Ingelheim is independent and
family-owned. We have the freedom to pursue our long-term vision,
looking ahead to identify the health challenges of the future and
targeting those areas of need where we can do the most good.
As a world-leading, research-driven pharmaceutical company, more
than 51,000 employees create value through innovation daily for our
three business areas: Human Pharma, Animal Health, and
Biopharmaceutical Contract Manufacturing. In 2019, Boehringer
Ingelheim achieved net sales of around $21.3
billion (19 billion euros).
Our significant investment of over $3.9
billion (3.5 billion euros) in
R&D drives innovation, enabling the next generation of
medicines that save lives and improve quality of life.
We realize more scientific opportunities by embracing the power
of partnership and diversity of experts across the life-science
community. By working together, we accelerate the delivery of the
next medical breakthrough that will transform the lives of patients
now, and in generations to come.
Boehringer Ingelheim Pharmaceuticals, Inc., based in
Ridgefield, CT, is the largest
U.S. subsidiary of Boehringer Ingelheim Corporation and is part of
the Boehringer Ingelheim group of companies. In addition,
there are Boehringer Ingelheim Animal Health in Duluth, GA and Boehringer Ingelheim Fremont,
Inc. in Fremont, CA.
Boehringer Ingelheim is committed to improving lives and
strengthening our communities. Please visit
www.boehringer-ingelheim.us/csr to learn more about Corporate
Social Responsibility initiatives.
For more information, please visit www.boehringer-ingelheim.us,
or follow us on Twitter @BoehringerUS.
About Lilly Diabetes
Lilly has been a global leader in
diabetes care since 1923, when we introduced the world's first
commercial insulin. Today we are building upon this heritage by
working to meet the diverse needs of people with diabetes and those
who care for them. Through research, collaboration and quality
manufacturing we strive to make life better for people affected by
diabetes and related conditions. We work to deliver breakthrough
outcomes through innovative solutions—from medicines and
technologies to support programs and more. For the latest updates,
visit http://www.lillydiabetes.com/ or follow us on Twitter:
@LillyDiabetes and Facebook: LillyDiabetesUS.
About Eli Lilly and Company
Lilly is a global health
care leader that unites caring with discovery to create medicines
that make life better for people around the world. We were founded
more than a century ago by a man committed to creating high-quality
medicines that meet real needs, and today we remain true to that
mission in all our work. Across the globe, Lilly employees work to
discover and bring life-changing medicines to those who need them,
improve the understanding and management of disease, and give back
to communities through philanthropy and volunteerism. To learn more
about Lilly, please visit us at lilly.com and
lilly.com/newsroom.
This press release contains forward-looking statements (as
that term is defined in the Private Securities Litigation Reform
Act of 1995) about Jardiance and reflects Lilly's current belief.
However, as with any pharmaceutical product, there are substantial
risks and uncertainties in the process of drug development and
commercialization. Among other things, there can be no guarantee
that future study results will be consistent with the results to
date or that Jardiance will receive additional regulatory
approvals. For a further discussion of these and other risks and
uncertainties that could cause actual results to differ from
Lilly's expectations, please see Lilly's most recent Forms 10-K and
10-Q filed with the U.S. Securities and Exchange Commission. Lilly
undertakes no duty to update forward-looking statements.
Jardiance® and EMPA-REG OUTCOME® are registered trademarks
of Boehringer Ingelheim.
P-LLY
MPR-US-101382
CONTACT:
Jennifer
Forsyth
Director, Public Relations
Boehringer Ingelheim Pharmaceuticals, Inc.
Email: jennifer.forsyth@boehringer-ingelheim.com
Phone: (203) 791-5889
Stephan Thalen
Global
Business Communications
Lilly Diabetes and Lilly USA
Email: stephan.thalen@lilly.com
Phone: (317) 903-5640
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