RIDGEFIELD, Conn., and
INDIANAPOLIS, March 23, 2015 /PRNewswire/ -- Glyxambi®
(empagliflozin/linagliptin) tablets are now available by
prescription in many leading chain and independent pharmacies
across the U.S., including Walgreens and Rite Aid. GLYXAMBI, part
of the Boehringer Ingelheim Pharmaceuticals, Inc. (BIPI) and Eli
Lilly and Company (NYSE: LLY) Diabetes alliance portfolio, is the
first and only dual inhibitor combination therapy approved in the
U.S. to combine the mechanisms of action of a sodium glucose
co-transporter-2 (SGLT2) inhibitor and a dipeptidyl peptidase-4
(DPP-4) inhibitor in a once-daily tablet.
GLYXAMBI is approved as an adjunct to diet and exercise to
improve glycemic control in adults with type 2 diabetes (T2D) when
both empagliflozin and linagliptin are appropriate treatments.
GLYXAMBI is a once-daily tablet taken in the morning that combines
10 mg or 25 mg of empagliflozin, an SGLT2 inhibitor, with 5 mg of
linagliptin, a DPP-4 inhibitor. GLYXAMBI is not for people with
type 1 diabetes or for diabetic ketoacidosis (increased ketones in
the blood or urine). If you have had pancreatitis (inflammation of
the pancreas) it is not known if you have a higher chance of
getting pancreatitis while taking GLYXAMBI.
"The rapid market availability of GLYXAMBI following its recent
FDA approval in late January is a reflection of Boehringer
Ingelheim and Lilly's commitment to bringing new treatment options
to people with type 2 diabetes," said Kathleen Dowd, senior vice president, marketing,
Boehringer Ingelheim Pharmaceuticals, Inc. "As the fourth diabetes
medicine to emerge from our alliance pipeline in the U.S., we
believe GLYXAMBI may help adults with type 2 diabetes lower their
blood sugar and manage their diabetes."
A GLYXAMBI savings card program is available online and in many
doctors' offices for patients who qualify. For terms and conditions
and any questions regarding eligibility or benefits, visit
GLYXAMBIsavings.com or call 1-855-GLYXAMBI (1-855-459-9262).
GLYXAMBI should not be taken if you have severe kidney problems,
are on dialysis or 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.
"As an add-on to metformin, GLYXAMBI was superior in reducing
A1C when compared with either empagliflozin or linagliptin alone,"
said David Kendall, M.D., vice
president, medical affairs, Lilly Diabetes. "The management of type
2 diabetes requires a personalized treatment plan, and GLYXAMBI
provides patients and their physicians with a new option to help
improve blood sugar control."
The U.S. Food and Drug Administration approval was based on a
phase III clinical trial that evaluated the efficacy and safety of
GLYXAMBI (10/5 mg and 25/5 mg) compared with the individual
components of empagliflozin (10 mg or 25 mg) or linagliptin (5 mg)
in adults with T2D who were also taking high-dose metformin (mean
dose 1889 mg daily). The study, which randomized 686 adults with
T2D and hemoglobin A1C (a measure of average blood glucose over the
past two to three months) between 7.0 and 10.5 percent, examined
the change from baseline in A1C at 24 weeks. The study demonstrated
superior A1C reduction with GLYXAMBI compared with the individual
components of empagliflozin or linagliptin. Starting from a mean
baseline of approximately 8.0 percent, adults in this trial
achieved a mean A1C of 6.9 and 6.7 percent with GLYXAMBI 10/5 mg
and 25/5 mg, respectively, compared with a mean A1C of 7.3 and 7.4
percent for empagliflozin 10 mg and 25 mg, respectively, and 7.3
percent for linagliptin 5 mg.
Data recently published in Diabetes Care demonstrated
that 58 percent and 62 percent of patients taking GLYXAMBI 10/5 mg
or 25/5 mg, respectively, in addition to metformin achieved an A1C
of less than 7 percent from a baseline A1C of approximately 8
percent, compared with 28 percent of patients taking empagliflozin
10 mg, 33 percent taking empagliflozin 25 mg and 36 percent taking
linagliptin 5 mg.
Through 52 weeks, the safety profile of GLYXAMBI was
demonstrated in a pooled analysis, and the most common adverse
reactions were urinary tract infection (UTI) (12.5 percent and 11.4
percent for GLYXAMBI 10/5 mg and 25/5 mg, respectively; through 52
weeks, no patient discontinued GLYXAMBI due to UTIs),
nasopharyngitis (5.9 percent and 6.6 percent for GLYXAMBI 10/5 mg
and 25/5 mg, respectively) and upper respiratory tract infection
(7.0 percent for GLYXAMBI 10/5 mg and 25/5 mg).
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.
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.
Visit GLYXAMBI.com for full Prescribing Information, including
Medication Guide.
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
adults diagnosed with diabetes in the U.S. Diabetes is a chronic
condition that occurs when the body either does not properly
produce, or use, the hormone insulin.
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 (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 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 and
newsroom.lilly.com/social-channels.
This press release contains forward looking statements about
GLYXAMBI for the treatment of type 2 diabetes along with diet and
exercise. 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 GLYXAMBI will be
commercially successful, or that it will receive additional
regulatory approvals. 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.
Glyxambi® is a trademark of Boehringer Ingelheim
Pharmaceuticals, Inc.
P-LLY
GLX646304PR
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://photos.prnewswire.com/prnh/20110825/DE57898LOGO
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/first-in-class-type-2-diabetes-treatment-glyxambi-empagliflozinlinagliptin-tablets-for-adults-now-available-in-us-pharmacies-300054038.html
SOURCE Eli Lilly and Company; Boehringer Ingelheim