RIDGEFIELD, Conn. and
INDIANAPOLIS, Oct. 21, 2014 /PRNewswire/ -- The U.S. Food and
Drug Administration (FDA) has accepted the filing of a New Drug
Application (NDA) for empagliflozin plus immediate-release
metformin hydrochloride fixed-dose combination, an investigational
compound being studied for the treatment of adults with type 2
diabetes (T2D). Empagliflozin plus metformin is part of the
Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY) Diabetes
alliance portfolio.
"Type 2 diabetes is a progressive condition, and many
patients eventually require multiple medications to manage their
blood sugar," said Christophe
Arbet-Engels, M.D., Ph.D., vice president,
metabolic-clinical development and medical affairs, Boehringer
Ingelheim Pharmaceuticals, Inc. "The FDA's acceptance of the NDA
for the empagliflozin plus metformin fixed-dose combination brings
us one step closer to offering a potential new treatment option
that may help patients better manage their type 2 diabetes through
one pill that combines two distinct approaches to help control
blood sugar."
Empagliflozin is a sodium glucose co-transporter-2 (SGLT2)
inhibitor, which removes excess glucose through the urine by
blocking glucose reabsorption in the kidney. Metformin, a commonly
prescribed initial treatment for T2D, decreases the production of
glucose in the liver and its absorption in the intestine and
improves the body's ability to utilize glucose.
The filing includes data from multiple clinical trials examining
the co-administration of empagliflozin and metformin in the
treatment of 4,740 adults with T2D.
Empagliflozin, marketed as Jardiance® (empagliflozin) tablets in
the U.S., was approved by the FDA in August
2014 as an adjunct to diet and exercise to improve glycemic
control in adults with T2D. JARDIANCE is not recommended for people
with type 1 diabetes or for the treatment of diabetic ketoacidosis
(increased ketones in the blood or urine).
About Diabetes
Approximately 29 million Americans and
an estimated 382 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
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.
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
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
- 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
- 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.
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. The alliance leverages the strengths of two of
the world's leading pharmaceutical companies. By joining forces,
the companies demonstrate commitment in the care of people 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 the Boehringer Ingelheim Cares Foundation Patient
Assistance Programs
For more than 125 years, Boehringer
Ingelheim has been focused on improving the lives of patients. In
keeping with the company commitment to do the most good for the
most people, Boehringer Ingelheim works hard to ensure its
medicines are accessible to everyone who needs them, including
senior citizens and families on limited incomes. The Boehringer
Ingelheim Cares Foundation Patient Assistance Programs (BI-PAP)
make Boehringer Ingelheim medicines available free of charge to
patients who are without pharmaceutical insurance coverage, and who
meet certain household income levels.
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 142
affiliates and more than 47,400 employees. Since it was founded in
1885, the family-owned company has been committed to researching,
developing, manufacturing and marketing novel medications of high
therapeutic value for human and veterinary medicine.
Social responsibility is a central element of Boehringer
Ingelheim's culture. 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 2013, Boehringer Ingelheim achieved net sales of about
$18.7 billion (14.1 billion euro). R&D expenditure in the
Prescription Medicines business corresponds to 19.5% of its net
sales.
For more information please
visit http://www.us.boehringer-ingelheim.com.
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, @LillyHealth on
Twitter and http://newsroom.lilly.com/social-channels.
This press release contains forward-looking statements about
an empagliflozin and metformin fixed-dose combination 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 an empagliflozin and metformin combination
tablet will prove to 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.
Jardiance® is a registered trademark of Boehringer
Ingelheim.
P-LLY
EMMT633104PR
CONTACT:
Emily Baier Geary
Public Relations
Boehringer Ingelheim Pharmaceuticals, Inc.
Email: emily.geary@boehringer-ingelheim.com
Phone: (203) 791-5997
Tammy Hull
Communications Manager
Lilly Diabetes
Email: hullta@lilly.com
Phone: (317) 651-9116
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SOURCE Eli Lilly and Company; Boehringer Ingelheim