RIDGEFIELD, Conn., and
INDIANAPOLIS, July 19, 2016 /PRNewswire/ -- The U.S. Food and
Drug Administration has approved an expanded indication for
Synjardy® (empagliflozin and metformin hydrochloride)
tablets to include treatment-naïve adults with type 2 diabetes
(T2D). SYNJARDY, from Boehringer Ingelheim and Eli Lilly and
Company (NYSE: LLY), is indicated as an adjunct to diet and
exercise to improve glycemic control in adults with T2D when
treatment with both empagliflozin and metformin is appropriate.
SYNJARDY is a combination of empagliflozin
(Jardiance®) and metformin — two medicines with
complementary mechanisms of action — to help control blood glucose
in adults with T2D. Empagliflozin, a sodium glucose
co-transporter-2 inhibitor, removes excess glucose through the
urine by blocking glucose re-absorption in the kidney. Metformin, a
commonly prescribed initial treatment for T2D, lowers glucose
production by the liver and its absorption in the intestine.
"Type 2 diabetes is a complex condition, which often requires
that people take more than one treatment to manage their blood
sugar," said Paul Fonteyne,
president and CEO, Boehringer Ingelheim Pharmaceuticals, Inc. "The
expanded indication for SYNJARDY further validates the potential of
this combination therapy to help adults with type 2 diabetes who
are not at goal, including those already being treated and, now,
those at the beginning of their treatment journey."
The SYNJARDY label was updated to include results from a phase
III, double-blind, randomized, active-controlled study that
evaluated the efficacy and safety of empagliflozin in combination
with metformin as initial therapy compared with the individual
components. In the study, at 24 weeks, the combination of
empagliflozin 10 mg or 25 mg with metformin 1000 mg or 2000 mg
resulted in significant reductions in A1C (a measure of average
blood glucose over the past two to three months) compared with the
corresponding dose of either component alone.
SYNJARDY can cause serious side effects, including Lactic
Acidosis (a buildup of lactic acid in the blood). Metformin, one of
the medicines in SYNJARDY, can cause lactic acidosis, a rare, but
serious condition that can cause death. Lactic acidosis is a
medical emergency and must be treated in a hospital. SYNJARDY is
not for the treatment of type 1 diabetes or diabetic
ketoacidosis.
About Diabetes
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. T2D 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 either does not properly produce, or use, the
hormone insulin.
What is SYNJARDY?
SYNJARDY is a prescription medicine
that contains 2 diabetes medicines, empagliflozin (JARDIANCE) and
metformin. SYNJARDY can be used along with diet and exercise
to lower blood sugar in adults with type 2 diabetes.
SYNJARDY 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
SYNJARDY?
SYNJARDY can cause serious side effects, including Lactic
Acidosis (a build-up of lactic acid in the blood). Metformin,
one of the medicines in SYNJARDY, can cause lactic acidosis, a
rare, but serious condition that can cause death. Lactic
acidosis is a medical emergency and must be treated in a
hospital.
Call your doctor right away if you get any of the following
symptoms of lactic acidosis: cold in your hands or feet; feel
dizzy or lightheaded; slow or irregular heartbeat; feel
very weak or tired; have unusual muscle pain; have trouble
breathing; feel sleepy or drowsy; have stomach pains, nausea, or
vomiting.
You have a higher chance of getting lactic acidosis with
SYNJARDY if you: have moderate to severe kidney problems or your
kidneys are affected by certain x-ray tests that use injectable
dye; have liver problems; drink alcohol very often, or drink a lot
of alcohol in the short-term ("binge" drinking); get dehydrated
(lose a large amount of body fluids); have surgery; have a heart
attack, severe infection, or stroke.
Who should not take SYNJARDY?
Do not take SYNJARDY if you:
- have moderate to severe kidney problems or are on dialysis
- have a condition called metabolic acidosis or diabetic
ketoacidosis (increased ketones in the blood or urine)
- are allergic to empagliflozin (JARDIANCE), metformin, or any of
the ingredients in SYNJARDY. Symptoms of serious allergic
reactions to SYNJARDY 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 SYNJARDY and contact your
doctor or go to the nearest emergency room right away
What should I tell my doctor before using SYNJARDY?
Tell your doctor about all of your medical conditions,
including if you:
- have moderate to severe kidney problems. Your doctor may do
blood tests to check your kidneys before and during treatment with
SYNJARDY
- have liver problems
- have a history of urinary tract infection or problems with
urination
- have heart problems, including congestive heart failure
- 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)
- are going to get an injection of dye or contrast agents for an
x-ray procedure. SYNJARDY may need to be stopped for a short time.
Talk to your doctor about when you should stop SYNJARDY and when
you should start SYNJARDY again
- have type 1 diabetes. SYNJARDY should not be used in people
with type 1 diabetes
- are pregnant or planning to become pregnant. SNYJARDY may harm
your unborn baby. Tell your doctor right away if you become
pregnant while taking SYNJARDY
- are a premenopausal woman (before the "change of life"), who
does not have periods regularly or at all. Talk to your doctor
about birth control choices while taking SYNJARDY as it may
increase your chances of becoming pregnant
- are breastfeeding or plan to breastfeed. SYNJARDY may pass into
your breast milk and may harm your baby. Do not breastfeed while
taking SYNJARDY.
Tell your doctor about all the medicines you take
including prescription or over-the-counter medicines, vitamins, or
herbal supplements.
What are the possible side effects of SYNJARDY?
SYNJARDY may cause serious side effects including:
Dehydration. SYNJARDY 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 higher risk of dehydration
if you have low blood pressure, kidney problems, are 65 years of
age or older, on a low salt diet, or take medicines to lower your
blood pressure, including water pills (diuretics).
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 SYNJARDY, even if blood sugar is less
than 250 mg/dL. Stop taking SYNJARDY 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 SYNJARDY 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.
Kidney problems. SYNJARDY can cause kidney
problems, especially in people 75 years of age or older and people
who already have kidney problems.
Low blood sugar (hypoglycemia). If you take
SYNJARDY with another medicine that can cause low blood sugar, such
as a sulfonylurea or insulin, your risk of getting low blood sugar
is higher. The dose of your sulfonylurea medicine or insulin may
need to be lowered. Symptoms of low blood sugar may include
headache, drowsiness, weakness, irritability, hunger, fast
heartbeat, confusion, shaking or feeling jittery, dizziness, or
sweating.
Vaginal yeast infection. Women who take SYNJARDY
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 SYNJARDY
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.
Low vitamin B12 (vitamin B12 deficiency). Using
metformin for long periods of time may cause a decrease in the
amount of vitamin B12 in your blood, especially if you have had low
vitamin B12 blood levels before. Your doctor may do blood tests to
check your vitamin B12 levels.
Increased fats in your blood (cholesterol).
The most common side effects of SYNJARDY include stuffy
or runny nose and sore throat, urinary tract infections, female
genital infections, diarrhea, headache, nausea, and vomiting.
These are not all the possible side effects of SYNJARDY.
For more information, ask your doctor or pharmacist.
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,
including Medication Guide.
SY CONS ISI 7.18.16
What is JARDIANCE?
JARDIANCE is a
prescription medicine used along with diet and exercise to lower
blood sugar in adults with type 2 diabetes. 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, especially in people 75 years of age or
older and people who already have kidney problems
- 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,
including Patient Information.
JAR CONS ISI 7.18.16
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 dollars (14.8 billion euros). R&D expenditure
corresponds to 20.3 percent of its net sales.
For more information please visit
www.us.boehringer-ingelheim.com, 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 broad and
growing product portfolio 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 SYNJARDY as a treatment of adults
with type 2 diabetes 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 SYNJARDY 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.
Synjardy® and Jardiance® are registered trademarks of Boehringer
Ingelheim.
P-LLY
PC-SY-0001-PR
CONTACT:
Lauren Murphy,
MBA
Associate Director, Public Relations
Boehringer Ingelheim Pharmaceuticals, Inc.
Email: lauren.murphy@boehringer-ingelheim.com
Phone: (203) 448-1982
Molly
McCully
Communications Manager
Lilly Diabetes
Email: mccully_molly@lilly.com
Phone: (317) 478-5423
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SOURCE Eli Lilly and Company; Boehringer Ingelheim