RIDGEFIELD, Conn. and
INDIANAPOLIS, Aug. 27, 2015 /PRNewswire/ -- The U.S. Food and
Drug Administration (FDA) has approved Synjardy® (empagliflozin and
metformin hydrochloride) tablets, from Boehringer Ingelheim
Pharmaceuticals, Inc. (BIPI) and Eli Lilly and Company (NYSE: LLY),
for the treatment of adults with type 2 diabetes (T2D). SYNJARDY is
the third product containing empagliflozin to be approved by the
FDA, following Jardiance® (empagliflozin) and Glyxambi®
(empagliflozin/linagliptin).
SYNJARDY is a combination of empagliflozin and metformin —
two medicines with complementary mechanisms of action — to
help control blood glucose in people with T2D. Empagliflozin, a
sodium glucose co-transporter-2 (SGLT2) 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.
"SYNJARDY is now the fifth FDA-approved medicine to emerge from
the BI-Lilly Diabetes alliance pipeline in the last four years,"
said Paul Fonteyne, president and
CEO, BIPI. "No two people with diabetes are alike, and every
experience is different. Our alliance is proud to offer a diverse
portfolio of treatments that can help patients throughout their
diabetes journey."
SYNJARDY is indicated as an adjunct to diet and exercise to
improve glycemic control in adults with T2D who are not adequately
controlled on a regimen containing empagliflozin or metformin, or
in patients already being treated with empagliflozin and metformin.
SYNJARDY is not for the treatment of type 1 diabetes or diabetic
ketoacidosis.
The SYNJARDY label contains a boxed warning for the risk of
lactic acidosis, a serious metabolic complication that can occur
due to metformin accumulation during treatment with SYNJARDY.
The FDA approval of SYNJARDY is based on results from multiple
clinical trials examining the co-administration of empagliflozin
and metformin, alone or in combination with sulfonylurea, in the
treatment of adults with T2D.
SYNJARDY was also recently approved by the European Medicines
Agency in May 2015.
About Diabetes
Approximately 29 million Americans and
an estimated 387 million people worldwide have type 1 or type 2
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 and
metformin. SYNJARDY can be used along with diet and exercise
to improve blood sugar in adults with type 2 diabetes who have
already been treated with either empagliflozin or metformin and
their blood sugar is not controlled well enough, or who are
currently taking both empagliflozin and metformin as separate
medicines.
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?
WARNING: RISK OF
LACTIC ACIDOSIS
Serious side effects
can happen in people taking SYNJARDY. Metformin, one of the
medicines in SYNJARDY, can cause a rare but serious condition
called lactic acidosis (a build-up of lactic acid in the blood)
that can cause death. Lactic acidosis is a medical emergency
and must be treated in a hospital.
Stop taking SYNJARDY
and call your doctor right away if you get any of the following
symptoms of lactic acidosis: you feel very weak or tired; have
unusual muscle pain; have trouble breathing; are very sleepy or
sleep longer than usual; have sudden stomach pains, nausea and
vomiting or diarrhea; feel cold, especially in your arms or legs;
feel dizzy or lightheaded; or have a slow or irregular heartbeat,
as these could be symptoms of lactic acidosis.
You have a higher
chance of getting lactic acidosis with SYNJARDY if you have kidney
problems, liver problems, congestive heart failure that requires
medicines, drink alcohol very often, or drink a lot of alcohol in
short-term "binge" drinking, get dehydrated (lose a large amount of
body fluids), have certain x-ray tests with dyes or contrast agents
that are injected into your body, have surgery, have a heart
attack, severe infection, or stroke, are 80 years of age or older
and have not had your kidneys tested.
|
Who should not take SYNJARDY?
Do not take SYNJARDY if you:
- have 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, 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 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
- drink alcohol very often, or drink a lot of alcohol in
short-term "binge" drinking
- are going to get an injection of dye or contrast agents for an
x-ray procedure. SYNJARDY will 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 is not for people with type 1
diabetes
- are pregnant or planning to become pregnant. It is not known if
SYNJARDY will harm your unborn baby. Tell your doctor right
away if you become pregnant during treatment with SYNJARDY
- are breastfeeding or plan to breastfeed. It is not known if
SYNJARDY passes into your breast milk
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, are on a low salt diet, or take medicines to lower
your blood pressure, including water pills (diuretics).
- 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.
- Kidney problems. SYNJARDY can cause kidney problems,
especially in people 75 years of age or older and people who
already have kidney problems.
- 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.
- Urinary tract infection. Tell your doctor if you have
any signs and symptoms of a urinary tract infection that may
include a burning feeling when passing urine, urine that looks
cloudy, pain in the pelvis, or back pain.
- 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.com or
call 1-800-FDA-1088.
For more information, please see Prescribing Information,
including Medication Guide.
SY CONS ISI 8.26.15
What is JARDIANCE
JARDIANCE is a once-daily pill
taken in the morning, used along with diet and exercise, to lower
blood sugar (A1C) 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.
- 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 the 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
- 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
- Confusion
- Sweating
- Drowsiness
- Irritability
- Shaking or feeling jittery
- Weakness
- Hunger
- Dizziness
- Fast heart beat
- Kidney Problems, especially in people 75 years of age or
older and people who already have kidney problems.
- Urinary Tract Infection: symptoms may include burning
feeling when passing urine, pain in the pelvis or back, or urine
that looks cloudy.
- 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 8.1.2014
What is GLYXAMBI?
GLYXAMBI is a prescription medicine
that contains 2 diabetes medicines, empagliflozin and
linagliptin. GLYXAMBI can be used along with diet and
exercise to lower blood sugar in adults with type 2 diabetes when
treatment with both empagliflozin and linagliptin is
appropriate.
IMPORTANT SAFETY INFORMATION
What is the most important information I should know
about GLYXAMBI?
Serious side effects can happen to people taking
GLYXAMBI, including:
- Inflammation of the pancreas (pancreatitis), which may
be severe and lead to death. Before you start taking GLYXAMBI, tell
your doctor if you have ever had pancreatitis, gallstones, a
history of alcoholism, or high triglyceride levels.
Stop taking GLYXAMBI and call your doctor right away if you have
pain in your stomach area (abdomen) that is severe and will not go
away. The pain may be felt going from your abdomen to your back.
The pain may happen with or without vomiting. These may be symptoms
of pancreatitis.
- Dehydration. GLYXAMBI 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, take medicines to lower your blood
pressure, including water pills (diuretics), are on a low salt
diet, have kidney problems, or are 65 years of age or older.
- Vaginal yeast infection. Women who take GLYXAMBI
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
GLYXAMBI 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 GLYXAMBI?
Do not take GLYXAMBI if you have severe kidney problems
or are on dialysis.
Do not take GLYXAMBI if you are allergic to empagliflozin
and linagliptin or any of the ingredients in GLYXAMBI.
Symptoms of a serious allergic
reaction to GLYXAMBI may include skin rash, itching, flaking or
peeling; raised red patches on your skin (hives); difficulty
swallowing or breathing; or swelling of your face, lips, tongue,
and throat that may cause difficulty breathing or swallowing. If
you have any of these symptoms, stop taking GLYXAMBI and call your
doctor or go to the emergency room right away.
What should I tell my doctor before using
GLYXAMBI?
Tell your doctor if you:
- have kidney problems. Your doctor may do blood tests to check
your kidneys before and during your treatment with GLYXAMBI
- have liver problems
- have a history of inflammation of your pancreas
(pancreatitis)
- have a history of infection of the vagina or penis
- have a history of urinary tract infections or problems with
urination
- have any other medical condition
- are pregnant or plan to become pregnant. It is unknown if
GLYXAMBI will harm your unborn baby. Tell your doctor right away if
you become pregnant during treatment with GLYXAMBI
- are breastfeeding, or planning to breastfeed. It is unknown if
GLYXAMBI 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. GLYXAMBI may affect the way other medicines
work, and other medicines may affect how GLYXAMBI works.
Especially tell your doctor if you take:
- insulin or other medicines that can lower your blood sugar
- diuretics (water pills)
- rifampin (Rifadin®, Rimactane®,
Rifater®, Rifamate®)*, an antibiotic that is
used to treat tuberculosis
*These trademarks are owned by third parties not affiliated with
GLYXAMBI.
What are the possible side effects of GLYXAMBI?
GLYXAMBI may cause serious side effects, including:
- Low blood sugar (hypoglycemia), if you take GLYXAMBI
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 or insulin may need to
be lowered. Signs and symptoms of low blood sugar may include
headache, drowsiness, weakness, confusion, irritability, hunger,
fast heartbeat, sweating, or feeling jittery.
- Urinary tract infections are a common side effect of
GLYXAMBI but can sometimes be serious. Symptoms may include
burning feeling when passing urine, urine that looks cloudy, and/or
pain in the pelvis or back.
- Allergic (hypersensitivity)
reactions can happen after your first dose or up to 3 months
after starting GLYXAMBI. Symptoms may include swelling of your
face, lips, throat, and other areas on your skin; difficulty with
swallowing or breathing; raised, red areas on your skin (hives);
and/or skin rash, itching, flaking, or peeling. If you have any of
these symptoms, stop taking GLYXAMBI and call your doctor or go to
the emergency room right away.
- Kidney problems, especially in people 75 years and older
and people who already have kidney problems
- Increased fats in your blood (cholesterol).
The most common side effects of GLYXAMBI include urinary tract
infections, stuffy or runny nose and sore throat, and upper
respiratory tract infections.
These are not all the possible side effects of GLYXAMBI. 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.
GLX CONS ISI 1.30.15
Visit GLYXAMBI.com for full Prescribing Information, including
Medication Guide.
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
146 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 2014, Boehringer Ingelheim achieved net sales of about
$16.96 billion dollars (13.3 billion euros). R&D expenditure
corresponds to 19.9 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, JARDIANCE and GLYXAMBI as treatments for
patients with type 2 diabetes along with diet and exercise 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, GLYXAMBI and 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.
Synjardy® is a registered trademark of Boehringer Ingelheim
P-LLY
PR-SY-0001
CONTACT:
Emily Baier
Geary
Public Relations
Boehringer Ingelheim Pharmaceuticals, Inc.
Email: emily.geary@boehringer-ingelheim.com
Phone: (203) 791-5997
Molly McCully
Communications Manager
Lilly Diabetes
Email: mccully_molly@lilly.com
Phone: (317) 478-5423
Logo -
http://photos.prnewswire.com/prnh/20031219/LLYLOGO
Logo -
http://photo.prnewswire.com/prnh/20110825/DE57898LOGO
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/us-fda-approves-synjardy-empagliflozinmetformin-hydrochloride-tablets-for-adults-with-type-2-diabetes-300134171.html
SOURCE Eli Lilly and Company; Boehringer Ingelheim