TIDMLEL
FDA approves Jentaduetotm (linagliptin/metformin hydrochloride) tablets for the
treatment of adult patients with type 2 diabetes
New treatment combines DPP-4 inhibitor, linagliptin (the active ingredient in
Tradjentatm (linagliptin) tablets), and metformin in a single tablet, taken
twice-daily, to lower blood sugar in adults with type 2 diabetes
Ridgefield, Conn., and Indianapolis, Jan. 30, 2012- Boehringer Ingelheim
Pharmaceuticals, Inc. and Eli Lilly and Company (NYSE: LLY) today announced the
U.S. Food and Drug Administration (FDA) has approved Jentaduetotm (linagliptin/
metformin hydrochloride) tablets, a new tablet combining the dipeptidyl
peptidase-4 (DPP-4) inhibitor, linagliptin, and metformin. JENTADUETO provides
a new, single-tablet treatment option, taken twice-daily, for patients who need
to control their blood sugar. Linagliptin (5 mg, once-daily) is marketed in the
U.S. as Tradjentatm (linagliptin) tablets.
JENTADUETO is a prescription medication used along with diet and exercise to
improve glycemic control in adults with type 2 diabetes when treatment with
both linagliptin and metformin is appropriate. At the maximum dose, JENTADUETO
demonstrated placebo-corrected reductions in hemoglobin A1c (HbA1c or A1C)
levels of up to 1.7 percent (+0.1 percent for placebo and -1.6 percent for
JENTADUETO). A1C is measured in people with diabetes to provide an index of
blood sugar control for the previous two to three months. JENTADUETO did not
cause any meaningful change in body weight. JENTADUETO can be used alone or in
combination with a sulfonylurea, a commonly prescribed medication for type 2
diabetes. JENTADUETO is not for the treatment of type 1 diabetes or diabetic
ketoacidosis (increased ketones in the blood or urine). It has not been studied
in combination with insulin. The JENTADUETO 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 JENTADUETO.
"Most people with type 2 diabetes require more than one medication to help
lower their blood sugar, due to the complex nature of type 2 diabetes," said
Lance Sloan, MD, Texas Institute for Kidney and Endocrine Disorders. "The
approval of JENTADUETO is exciting because it combines two diabetes medications
in a single tablet, making it a good option for people who need an additional
medication, and for whom both linagliptin and metformin is appropriate."
JENTADUETOClinical Trials
In a 24-week, randomized, double-blind, placebo-controlled factorial study
evaluating 791 adult patients with type 2 diabetes and inadequate glycemic
control with diet and exercise, linagliptin plus metformin demonstrated the
following:
Placebo 5 mg 500 mg m 2.5 mg 1,000 mg m 2.5 mg
linagliptin etformin linagliptin etformin linagliptin/
once-daily / 500 mg twice-daily 1,000 mg
twice-daily metformin metformin
twice-daily twice-daily
A1C (%)
Change +0.1 -0.5 -0.6 -1.2 -1.1 -1.6
from
baseline
(adjusted
mean)
Difference -- -0.6 -0.8 -1.3 -1.2 -1.7
from
placebo
(adjusted
mean)
*FPG (mg/dL)
Change +10 -9 -16 -33 -32 -49
from
baseline
(adjusted
mean)
Difference -- -19 -26 -43 -42 -60
from
placebo
(adjusted
mean)
*Fasting plasma glucose (FPG) is used to determine glucose levels in a fasting
state (usually upon waking in the morning).
JENTADUETO was approved based on clinical trials that evaluated linagliptin and
metformin as separate tablets. Bioequivalence of JENTADUETO was demonstrated
with co-administered linagliptin and metformin tablets in healthy subjects.
Adverse reactions reported in greater than or equal to five percent of patients
treated with JENTADUETO and more commonly than in patients treated with placebo
included nasopharyngitis (the common cold) and diarrhea. Hypoglycemia was more
commonly reported in patients treated with the combination of JENTADUETO and
sulfonylurea compared with those treated with the combination of placebo,
sulfonylurea and metformin (22.9 percent versus 14.8 percent, respectively).
Pancreatitis was reported more often in patients randomized to linagliptin (1
per 538 person years versus zero in 433 person years for comparator).
"We are proud to bring this important, new, single-tablet treatment option,
taken twice-daily, to the millions of people currently living with type 2
diabetes," said David Pass, PharmD, vice president, cardiovascular and
metabolic disorders marketing, Boehringer Ingelheim Pharmaceuticals, Inc. "We
are hopeful that JENTADUETO, the newest member of the growing family of
products from the Boehringer Ingelheim and Lilly diabetes alliance, may help
people living with blood sugar levels that are not controlled."
The FDA approval of JENTADUETO marks the second U.S. approval since the
formation of the Boehringer Ingelheim and Lilly worldwide diabetes alliance in
January 2011. The alliance leverages the collective scientific expertise and
business capabilities of two leading research-driven pharmaceutical companies
to address patient needs arising from the growing global diabetes epidemic.
What is JENTADUETO?
JENTADUETO is a prescription medicine that contains 2 diabetes medicines,
linagliptin and metformin. JENTADUETO can be used along with diet and exercise
to help control blood sugar in adults with type 2 diabetes when treatment with
both linagliptin and metformin is appropriate.
JENTADUETO is not for people with type 1 diabetes or for people with diabetic
ketoacidosis (increased ketones in the blood or urine).
It is not known if JENTADUETO is safe and effective when used with insulin.
IMPORTANT SAFETY INFORMATION
What is the most important information I should know about JENTADUETO?
WARNING: RISK OF LACTIC ACIDOSIS
Serious side effects can happen in people taking JENTADUETO. Metformin, one
of the medicines in JENTADUETO, 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 JENTADUETO and call your doctor right away if you feel very weak
or tired, have unusual muscle pain, have trouble breathing, are very sleepy,
have sudden 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 JENTADUETO 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-rays tests with dyes or contrast agents that are injected into your
body, have surgery, have a heart attack, severe infection, or stroke, and are
80 years of age or older and have not had your kidneys tested.
Who should not take JENTADUETO?
Do not take JENTADUETO if you:
* have kidney problems
* have a condition called metabolic acidosis or diabetic ketoacidosis
(increased ketones in the blood or urine)
* are allergic to linagliptin, metformin or any of the ingredients in
JENTADUETO. Symptoms of any allergic reaction are rash, raised red patches
on your skin (hives), and swelling of your face, lips, and throat that may
cause difficulty breathing or swallowing. If you have any symptoms of a
serious allergic reaction, stop taking JENTADUETO and call your doctor
right away.
What should I tell my doctor before using JENTADUETO?
Before you take JENTADUETO, tell your doctor if you:
* have kidney problems
* are going to get an injection of dye or contrast agents for an x-ray
procedure. JENTADUETO will need to be stopped for a short time. Talk to
your doctor about when you should stop JENTADUETO and when you should start
JENTADUETO again.
* have liver problems
* have heart problems, including congestive heart failure
* drink alcohol very often, or drink a lot of alcohol in short term "binge"
drinking
* have any other medical conditions
* are pregnant or planning to become pregnant. It is not known if JENTADUETO
will harm your unborn baby. If you are pregnant, talk with your doctor
about the best way to control your blood sugar while you are pregnant.
* are breast-feeding or plan to breast-feed. It is not known if JENTADUETO
passes into your breast milk. Talk with your doctor about the best way to
feed your baby if you take JENTADUETO.
Tell your doctor about all the medicines you take, including prescription and
non-prescription medicines, vitamins, and herbal supplements. JENTADUETO may
affect the way other medicines work, and other medicines may affect how
JENTADUETO works.
Especially tell your doctor if you take:
* other medicines that can lower your blood sugar. JENTADUETO may cause
serious side effects, including low blood sugar (hypoglycemia), which may
become worse in people who already take another medication to treat
diabetes, such as a sulfonylurea or insulin. Tell your healthcare provider
if you take other diabetes medicines. Your doctor may prescribe lower doses
of the sulfonylurea medicine.
If you have symptoms of low blood sugar, you should check your blood sugar and
treat it if it is low, then call your healthcare provider. Symptoms of low
blood sugar include shaking, rapid heartbeat, hunger, headache, sweating,
change in vision, and change in mood.
* rifampin (Rifadine®, Rimactane®, Rifater®, Rifamate®), an antibiotic that
is used to treat tuberculosis.
Ask your doctor or pharmacist for a list of these medicines if you are not sure
if your medicine is one that is listed above.
Know the medicines you take. Keep a list of them and show it to your doctor and
pharmacist when you get a new medicine.
What are the possible side effects of JENTADUETO tablets?
The most common side effects of JENTADUETO include:
* stuffy or runny nose and sore throat
* diarrhea
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.
Please see Important Safety Information for Warning about the Risk of Lactic
Acidosis, and full Prescribing Information, including Patient Information for
additional safety information.
To learn more about JENTADUETO visit http://www.JENTADUETO.com. For full
prescribing information visit http://us.boehringer-ingelheim.com/content/dam/
internet/opu/us_EN/documents/products/JENTADUETO.PDF or call Boehringer
Ingelheim Pharmaceuticals, Inc. at 1-800-542-6257, or (TTY) 1-800-459-9906.
Please report any unexpected effects or product problems to the Boehringer
Ingelheim Drug Information Unit by calling 1-800-542-6257.
What are TRADJENTA tablets?
TRADJENTA is a prescription medicine that is used along with diet and exercise
to lower blood sugar in adults with type 2 diabetes.
Tradjenta is not for people with type 1 diabetes or for people with diabetic
ketoacidosis (increased ketones in the blood or urine).
It is not known if TRADJENTA is safe and effective when used with insulin.
Important Safety Information
Who should not take TRADJENTA?
Do not take TRADJENTA if you are allergic to linagliptin or any of the
ingredients in TRADJENTA.
Symptoms of a serious allergic reaction to TRADJENTA are rash, raised red
patches on your skin (hives), swelling of your face, lips, and throat that may
cause difficulty breathing or swallowing. If you have any symptoms of a serious
allergic reaction, stop taking TRADJENTA and call your doctor right away.
What should I tell my doctor before taking TRADJENTA?
Tell your doctor if you take other medicines that can lower your blood sugar,
such as a sulfonylurea or insulin.
TRADJENTA may cause serious side effects, including low blood sugar
(hypoglycemia). If you take TRADJENTA with another medicine that can cause low
blood sugar, such as 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 while you take TRADJENTA.
Signs and symptoms of low blood sugar may include headache, drowsiness,
weakness, dizziness, confusion, irritability, hunger, fast heartbeat, sweating,
or feeling jittery.
Also tell your doctor if you take rifampin (Rifadin®, Rimactane®, Rifater®,
Rifamate®), an antibiotic that is used to treat tuberculosis.
TRADJENTA may affect the way other medicines work, and other medicines may
affect how TRADJENTA works.
Tell your doctor if you are pregnant or planning to become pregnant or are
breastfeeding or plan to breastfeed.
Tell your doctor about all the medicines you take, including prescription and
non-prescription medicines, vitamins, and herbal supplements.
What are the possible side effects of TRADJENTA?
The most common side effects of TRADJENTA include stuffy or runny nose and sore
throat.
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 safety information, please see Patient Information and full
Prescribing Information.
Replacement Card
If you are already enrolled in the TRADJENTA Savings Card Program and need a
replacement card please call the TRADJENTA Savings Card Program at
1-877-512-4246. Our customer service representatives are available to assist
you.
To learn more about TRADJENTA and for full prescribing information visit: http:
//www.TRADJENTA.com or call Boehringer Ingelheim Pharmaceuticals, Inc. at
1-800-542-6257.
Please report any unexpected effects or product problems to the Boehringer
Ingelheim Drug Information Unit by calling 1-800-542-6257.
About JENTADUETO
JENTADUETO combines two medicines that demonstrated improvements in blood sugar
control: the DPP-4 inhibitor, linagliptin, and metformin. Linagliptin (5 mg,
once-daily) is marketed in the U.S. as TRADJENTA.
TRADJENTA has demonstrated significant reductions in A1C when used as
monotherapy and in combination with metformin, sulfonylurea and pioglitazone.
Metformin is a commonly used antihyperglycemic medication that improves glucose
tolerance by lowering both basal and postprandial plasma glucose.
About Diabetes
Approximately 25.8 million Americans1 and an estimated 366 million people2
worldwide have diabetes, according to 2010 data from CDC and 2011 data from
IDF. Type 2 diabetes is the most common type, accounting for an estimated 90 to
95 percent of all diabetes cases.1 Diabetes is a chronic disease that occurs
when the body either does not properly produce, or use, the hormone insulin.3
About Boehringer Ingelheim and Eli Lilly and Company
In January 2011, Boehringer Ingelheim and Eli Lilly and Company announced an
alliance in the field of diabetes that centers on four pipeline compounds
representing several of the largest treatment classes. This alliance leverages
the companies' strengths as two of the world's leading pharmaceutical
companies, combining Boehringer Ingelheim's solid track record of
research-driven innovation and Lilly's innovative research, experience, and
pioneering history in diabetes. 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 http://
www.boehringer-ingelheim.com or http://www.lilly.com.
About Boehringer Ingelheim Pharmaceuticals, Inc.
Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, CT, is the
largest U.S. subsidiary of Boehringer Ingelheim Corporation (Ridgefield, CT)
and a member of the Boehringer Ingelheim group of companies.
The Boehringer Ingelheim group is one of the world's 20 leading pharmaceutical
companies. Headquartered in Ingelheim, Germany, it operates globally with 145
affiliates and more than 42,000 employees. Since it was founded in 1885, the
family-owned company has been committed to researching, developing,
manufacturing and marketing novel products of high therapeutic value for human
and veterinary medicine.
As a central element of its culture, Boehringer Ingelheim pledges to act
socially responsible. Involvement in social projects, caring for employees and
their families, and providing equal opportunities for all employees form the
foundation of the global operations. Mutual cooperation and respect, as well as
environmental protection and sustainability are intrinsic factors in all of
Boehringer Ingelheim's endeavors.
In 2010, Boehringer Ingelheim posted net sales of approximately $16.7 billion
(about 12.6 billion euro) while spending almost 24 percent of net sales in its
largest business segment, Prescription Medicines, on research and development.
For more information, please visit http://us.boehringer-ingelheim.com and
follow us on Twitter at http://twitter.com/boehringerus.
About Eli Lilly and Company
Lilly, a leading innovation-driven corporation, is developing a growing
portfolio of pharmaceutical products by applying the latest research from its
own worldwide laboratories and from collaborations with eminent scientific
organizations. Headquartered in Indianapolis, IN, Lilly provides answers -
through medicines and information - for some of the world's most urgent medical
needs. Additional information about Lilly is available at http://www.lilly.com.
About Lilly Diabetes
For more than 85 years, Lilly has been a worldwide leader in pioneering
industry-leading solutions to support people living with and treating diabetes.
Lilly introduced the world's first commercial insulin in 1923, and remains at
the forefront of medical and delivery device innovation to manage diabetes.
Lilly is also committed to providing solutions beyond therapy - practical
tools, education, and support programs to help overcome barriers to success
along the diabetes journey. At Lilly, the journeys of each person living with
or treating diabetes inspire ours. For more information, visit http://
www.lillydiabetes.com.
This press release contains forward-looking statements about JENTADUETO and
TRADJENTA for the treatment of type 2 diabetes. It reflects Lilly's current
beliefs; however, as with any such undertaking, there are substantial risks and
uncertainties in the process of drug development and commercialization. There
is no guarantee that future study results and patient experience will be
consistent with study findings to date or that JENTADUETO or TRADJENTA will be
commercially successful. For further discussion of these and other risks and
uncertainties, please see Lilly's latest Forms 10-Q and 10-K filed with the
U.S. Securities and Exchange Commission. Lilly undertakes no duty to update
forward-looking statements.
P-LLY
###
CONTACT:
Anna Moses
Public Affairs & Communications
Boehringer Ingelheim Pharmaceuticals, Inc.
Email: usnews@boehringer-ingelheim.com
Phone: (203) 798-4638
Tammy Hull
Communications Manager
Lilly Diabetes
Email: hullta@lilly.com
Phone: (317) 651-9116
1Centers for Disease Control and Prevention. National Diabetes Fact Sheet 2011.
Available at: http://www.cdc.gov/diabetes/pubs/pdf/ndfs_2011.pdf. Accessed on:
January 23, 2012.
2 International Diabetes Federation. Diabetes Atlas Fact Sheet. 5th edn.
Brussels: International Diabetes Federation, 2011.
3 International Diabetes Federation. Diabetes Atlas. 3rd edn. Brussels:
International Diabetes Federation, 2006.
JD127402 PR
Press Release
For U.S. Media
JD127402 PR
Page 9
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