RIDGEFIELD, Conn. and
INDIANAPOLIS, Dec. 5, 2016 /PRNewswire/ -- The U.S. Food and
Drug Administration (FDA) approved a new indication for
Jardiance® (empagliflozin) tablets to reduce the
risk of cardiovascular death in adults with type 2 diabetes and
established cardiovascular disease. JARDIANCE is the first type 2
diabetes treatment approved with this additional indication and the
only oral type 2 diabetes medicine shown in a clinical trial to
provide a life-saving cardiovascular benefit. JARDIANCE is
marketed by Boehringer Ingelheim and Eli Lilly and Company (NYSE:
LLY).
Experience the interactive Multimedia News Release here:
https://www.multivu.com/players/English/7965451-bi-lilly-jardiance-cv-fda
"As the only diabetes treatment approved by the FDA to reduce
the risk of cardiovascular death, JARDIANCE represents a tremendous
step forward in our efforts to reduce the impact of heart disease
among adults with type 2 diabetes and cardiovascular disease," said
Paul Fonteyne, president and CEO,
Boehringer Ingelheim Pharmaceuticals, Inc. "This approval is
another example of our commitment to the discovery and development
of treatment options for adults with type 2 diabetes. We believe
that JARDIANCE is an important treatment option for this patient
population."
JARDIANCE is not for people with type 1 diabetes or people with
diabetic ketoacidosis (increased ketones in the blood or
urine).
The approval is based on breakthrough evidence from the landmark
EMPA-REG OUTCOME® trial, which investigated the effects
of JARDIANCE compared with placebo when added to standard of care
type 2 diabetes and cardiovascular medicines in adults with type 2
diabetes and established cardiovascular disease. In the trial,
JARDIANCE significantly reduced the risk of the combined primary
endpoint of cardiovascular death, non-fatal heart attack or
non-fatal stroke by 14 percent versus placebo (HR 0.86, 95% CI:
0.74-0.99); absolute risk reduction was 1.6 percent for JARDIANCE
versus placebo. This primary finding was driven by a significant 38
percent reduction in the risk of cardiovascular death (HR 0.62, 95%
CI: 0.49-0.77); absolute risk reduction was 2.2 percent for
patients taking JARDIANCE versus placebo. There was no change in
the risk of non-fatal heart attack (HR 0.87, 95% CI: 0.70-1.09) or
non-fatal stroke (HR 1.24, 95% CI: 0.92-1.67). The cardiovascular
benefits of JARDIANCE were consistent among patient subgroups.
Adults with type 2 diabetes should not take JARDIANCE if they
have severe kidney problems or are on dialysis, or if they are
allergic to empagliflozin or any ingredient in JARDIANCE. JARDIANCE
can cause dehydration and low blood pressure. JARDIANCE can also
cause increased ketones in the blood (ketoacidosis), serious
urinary tract infection, acute kidney injury and impairment in
renal function, low blood glucose when used with insulin or insulin
secretagogues (e.g., sulfonylurea, a medication used to treat type
2 diabetes), vaginal yeast infections and yeast infections of the
penis, and increased cholesterol.
"People with diabetes are two to four times more likely to
develop cardiovascular disease than people without diabetes. The
new indication for empagliflozin enables physicians for the first
time to provide adults with type 2 diabetes with a diabetes
medication that can reduce their risk of dying from cardiovascular
disease," said Christopher P.
Cannon, M.D., Cardiovascular Division, Brigham and Women's
Hospital and professor of medicine, Harvard
Medical School. "It also gives physicians an opportunity to
speak with and educate people with type 2 diabetes about their
increased risk for cardiovascular disease and to help them
understand this serious complication of their condition."
"Despite significant medical advances, approximately two out of
three people with type 2 diabetes still die from cardiovascular
disease. The Boehringer Ingelheim and Lilly diabetes alliance is
proud to bring a groundbreaking innovation to millions of adults
with type 2 diabetes and established cardiovascular disease," said
Enrique Conterno, senior vice
president and president, Lilly Diabetes. "As part of our ongoing
commitment to people with type 2 diabetes, we are also expanding
our efforts to educate the public on the link between
cardiovascular disease and type 2 diabetes."
In 2014, JARDIANCE was approved by the FDA as an adjunct to diet
and exercise to improve glycemic control, or blood glucose levels,
in adults with type 2 diabetes.
About the EMPA-REG OUTCOME Trial
(NCT01131676)
EMPA-REG OUTCOME was a long-term, multicenter,
randomized, double-blind, placebo-controlled trial of more than
7,000 patients, from 42 countries, with type 2 diabetes and
established cardiovascular disease.
The study assessed the effect of JARDIANCE (10 mg or 25 mg once
daily) added to standard of care compared with placebo added to
standard of care. Standard of care was comprised of
glucose-lowering agents and cardiovascular drugs (including for
blood pressure and cholesterol). The primary endpoint was defined
as time to first occurrence of cardiovascular death, non-fatal
heart attack or non-fatal stroke.
The safety profile of JARDIANCE in the EMPA-REG OUTCOME trial
was consistent with that of previous trials.
About Diabetes and Cardiovascular Disease
Approximately 29 million Americans and an estimated 415 million
people worldwide have diabetes, and nearly 28 percent of Americans
with diabetes—totaling 8 million people—are undiagnosed. In the
U.S., approximately 12 percent of those aged 20 and older have
diabetes. Type 2 diabetes is the most common type, accounting for
an estimated 90 to 95 percent of all diagnosed adult diabetes cases
in the U.S. Diabetes is a chronic condition that occurs when the
body does not properly produce or use the hormone insulin.
Due to the complications associated with diabetes, such as high
blood sugar, high blood pressure and obesity, cardiovascular
disease is a major complication and the leading cause of death
associated with diabetes. People with diabetes are two to four
times more likely to develop cardiovascular disease than people
without diabetes. Approximately 50 percent of deaths in people with
type 2 diabetes worldwide and 68 percent of deaths in people with
type 2 diabetes in the U.S. are caused by cardiovascular disease.
In the U.S., health care costs for managing cardiovascular
conditions in patients with diabetes totaled more than $23 billion in 2012.
Having diabetes can shorten a person's lifespan by as much as
six years compared with someone without diabetes.* And having both
diabetes and a history of heart attack or stroke can shorten a
person's lifespan by as much as 12 years compared with someone
without these conditions.**
* Based on having a history of diabetes at age 60.
** Based on having a history of diabetes and heart attack or stroke
at age 60.
About Educational Initiatives
Given the critical
connection between diabetes and cardiovascular disease, Boehringer
Ingelheim and Eli Lilly and Company are committed to providing a
wide range of diabetes therapies along with programs and support to
raise awareness, understanding and action toward reducing the
impact of cardiovascular disease in people with type 2
diabetes.
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 reduces 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
What is the most important information I should
know about JARDIANCE?
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.
- 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. 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
- 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.
- 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.
Who should not take JARDIANCE?
Do not
take JARDIANCE if you are allergic to empagliflozin or any of
the ingredients in JARDIANCE. Symptoms of serious allergic
reactions to JARDIANCE may include:
- skin rash
- raised red patches on your skin (hives)
- swelling of the face, lips, tongue, and throat that may cause
difficulty breathing or swallowing.
If you have any of these symptoms, stop taking JARDIANCE and
contact your doctor or go to the nearest emergency room right
away.
Do not take JARDIANCE if you have severe kidney problems
or are on dialysis.
What should I tell my doctor before using
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
- are eating less due to illness, surgery, or 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 planning to become pregnant. It is unknown if
JARDIANCE will harm your unborn baby
- are breastfeeding, or plan to breastfeed. It is unknown if
JARDIANCE passes into your breast milk.
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.
What are other possible side effects of
JARDIANCE?
- 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 heart beat
- Sweating
- Shaking or feeling jittery
- 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.
- Increased fats in your blood (cholesterol).
The most common side effects of JARDIANCE
include urinary tract infections, and yeast infections in
females.
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 full Prescribing Information
and Patient Information.
JAR CONS ISI 12.2.16
Boehringer Ingelheim and Eli Lilly and Company
In
January 2011, Boehringer Ingelheim
and Eli Lilly and Company announced an alliance in diabetes that
centers on compounds representing several of the largest diabetes
treatment classes. This alliance leverages the strengths of two of
the world's leading pharmaceutical companies. By joining forces,
the companies demonstrate commitment in the care of patients with
diabetes and stand together to focus on patient needs. Find out
more about the alliance at www.boehringer-ingelheim.com or
www.lilly.com.
About Boehringer Ingelheim
Boehringer Ingelheim
Pharmaceuticals, Inc., based in Ridgefield, CT, is the largest U.S. subsidiary
of Boehringer Ingelheim Corporation.
Boehringer Ingelheim is one of the world's 20 leading
pharmaceutical companies. Headquartered in Ingelheim, Germany, the company operates globally with
145 affiliates and more than 47,000 employees. Since its founding
in 1885, the family-owned company has been committed to
researching, developing, manufacturing and marketing novel
treatments for human and veterinary medicine.
Boehringer Ingelheim is committed to improving lives and
providing valuable services and support to patients and families.
Our employees create and engage in programs that strengthen our
communities. To learn more about how we make more health for more
people, visit our Corporate Social Responsibility Report.
In 2015, Boehringer Ingelheim achieved net sales of about
$15.8 billion (14.8 billion euros). R&D expenditure
corresponds to 20.3 percent of its net sales.
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 and collaboration, a wide range
of therapies and a continued determination to provide real
solutions—from medicines to support programs and more—we strive to
make life better for all those affected by diabetes around the
world. For more information, visit www.lillydiabetes.com.
About Eli Lilly and Company
Lilly is a global
healthcare leader that unites caring with discovery to 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 www.lilly.com and
newsroom.lilly.com/social-channels.
This press release contains forward-looking statements (as
that term is defined in the Private Securities Litigation Reform
Act of 1995) about JARDIANCE as a treatment of adults
with type 2 diabetes and established cardiovascular disease, and
reflects Lilly's current belief. However, as with any
pharmaceutical product, there are substantial risks and
uncertainties in the process of 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
further discussion of these and other risks and uncertainties, see
Lilly's most recent Form 10-K and Form 10-Q filings with the United
States Securities and Exchange Commission. Except as required by
law, Lilly undertakes no duty to update forward-looking statements
to reflect events after the date of this release.
Jardiance® and EMPA-REG OUTCOME® are
registered trademarks of Boehringer Ingelheim.
P-LLY
PC-JAR-0015-PR
CONTACT:
Jennifer
Forsyth
Director, Public Relations
Boehringer Ingelheim Pharmaceuticals, Inc.
Email: jennifer.forsyth@boehringer-ingelheim.com
Phone: (203) 791-5889
Molly
McCully
Communications Manager
Lilly Diabetes
Email: mccully_molly@lilly.com
Phone: (317) 478-5423
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