RIDGEFIELD, Conn. and INDIANAPOLIS, Nov. 11, 2021 /PRNewswire/ -- The U.S. Food
and Drug Administration (FDA) has accepted a supplemental New Drug
Application (sNDA) and granted Priority Review for
Jardiance® (empagliflozin) 10 mg, which is being
investigated as a potential new treatment to reduce the risk of
cardiovascular death plus hospitalization for heart failure in
adults with heart failure independent of left ventricular ejection
fraction (LVEF), Boehringer Ingelheim and Eli Lilly and Company
(NYSE: LLY) announced.
"If approved, Jardiance would be the first and only therapy
clinically proven to significantly improve outcomes in a heart
failure population that included a majority of people with
preserved ejection fraction," said Mohamed
Eid, M.D., M.P.H., M.H.A., vice president, Clinical
Development & Medical Affairs, Cardio-Metabolism &
Respiratory Medicine, Boehringer Ingelheim Pharmaceuticals, Inc.
"Building on the recent FDA approval of Jardiance for heart failure
with reduced ejection fraction, this supplemental New Drug
Application acceptance is a step toward the potential to make
Jardiance the sole treatment to demonstrate a statistically
significant benefit for adults across the full spectrum of heart
failure regardless of ejection fraction. The FDA's Priority Review
designation further reinforces the urgent need for additional
treatments for heart failure."
The sNDA is based on results from the
EMPEROR-Preserved® phase III trial, in which Jardiance
was associated with a 21% relative risk reduction (3.3% absolute
risk reduction) for the composite primary endpoint of
cardiovascular death or hospitalization for heart failure in adults
with heart failure with LVEF over 40% compared with placebo.
Results were independent of ejection fraction or diabetes status.
Results from EMPEROR-Preserved were presented at the European
Society of Cardiology Congress 2021 and published in The New
England Journal of Medicine.
According to the FDA, a Priority Review designation is intended
to direct overall attention and resources to the evaluation of
applications for a treatment that, if approved, would be a
significant improvement in the safety or effectiveness of
treatments for serious conditions. In September, the FDA also
granted Breakthrough Therapy designation to Jardiance as an
investigational treatment for adults with heart failure with
preserved ejection fraction (HFpEF).
Jardiance is currently indicated to reduce the risk
of cardiovascular death plus hospitalization for heart failure
in adults with heart failure and reduced ejection fraction.
Jardiance is not for type 1 diabetes, or to improve glycemic
control in adults with type 2 diabetes with an eGFR <30
mL/min/1.73m2. Jardiance
is contraindicated in people with hypersensitivity to empagliflozin
or any of the excipients in Jardiance, and in patients on dialysis.
Please see additional Important Safety Information
below.
HFpEF accounts for approximately half of the more than 6 million
heart failure cases in the U.S. No currently approved treatments
have been clinically proven to significantly improve outcomes
specifically for people with HFpEF.
"This milestone offers renewed hope to adults with heart failure
with preserved ejection fraction, for whom treatment options are
especially lacking," said Jeff
Emmick, M.D., Ph.D., vice president, Product Development,
Lilly. "We believe Jardiance has the potential to be a
transformative treatment in heart failure and look forward to
working with the FDA during the review process toward a decision
next year."
The FDA previously granted Fast Track designation for the
development of Jardiance to reduce the risk of cardiovascular
death and hospitalization for heart failure. The Fast Track
designation is for the EMPEROR program, which consists of the
EMPEROR-Reduced® and EMPEROR-Preserved
trials. The EMPEROR-Reduced results formed the basis of the recent
FDA approval for heart failure with reduced ejection fraction.
Jardiance is not indicated for the treatment of HFpEF.
About EMPEROR-Preserved
EMPEROR-Preserved (NCT03057951) was a phase III international,
randomized, double-blind trial that enrolled 5,988 adults with and
without type 2 diabetes. All participants had heart failure (New
York Heart Association [NYHA] functional class II, III or IV) and
LVEF over 40%; 4,005 (67%) had HFpEF (LVEF of at least 50%), and
1,983 (33%) had mildly reduced LVEF (greater than 40% but less than
50%).
Participants were randomized to once-daily Jardiance 10 mg
(n=2997) or placebo (n=2991), on top of treatment with
guideline-directed heart failure therapy. Median follow-up time was
26.2 months. The composite primary endpoint was defined as time to
first event of cardiovascular death or hospitalization for heart
failure.
What is JARDIANCE?
(www.jardiance.com)
JARDIANCE is a prescription medicine used to:
- lower blood sugar along with diet and exercise in adults with
type 2 diabetes
- reduce the risk of cardiovascular death in adults with type 2
diabetes who also have known cardiovascular disease
- reduce the risk of cardiovascular death and hospitalization for
heart failure (when the heart is weak and cannot pump enough blood
to the rest of your body) in adults with heart failure
JARDIANCE is not for people with type 1
diabetes. It may increase their risk of diabetic
ketoacidosis (increased ketones in the blood or
urine).
JARDIANCE is not for use to lower blood sugar in adults with
type 2 diabetes who have severe kidney problems, because it may not
work.
IMPORTANT SAFETY INFORMATION
Do not take
JARDIANCE if you are allergic to
empagliflozin or any of the ingredients in
JARDIANCE.
Do not take JARDIANCE if you are
on dialysis.
JARDIANCE can cause serious side effects, including:
- Ketoacidosis (increased ketones in your blood or
urine). Ketoacidosis is a serious condition which needs 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. Ketoacidosis has also
happened in people with diabetes who were sick or who had surgery
during treatment with JARDIANCE. Stop taking JARDIANCE and call
your healthcare provider right away or go to the nearest hospital
emergency room 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
- Dehydration. JARDIANCE can cause some people
to become dehydrated (the
loss of body water and salt).
Dehydration may cause you to feel dizzy,
faint, light-headed,
or weak, especially when you stand up. Sudden
worsening of kidney function has happened in people who are taking
JARDIANCE.
You may be at a
higher risk of dehydration if you:
-
- 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
Talk to your healthcare provider
about what you can do to prevent dehydration, including how much
fluid you should drink on a daily basis, and if you reduce the
amount of food or liquid you drink, if you are sick or cannot eat,
or start to lose liquids from your body from vomiting, diarrhea, or
being in the sun too long.
- Serious urinary tract infections. Serious urinary
tract infections can occur in people taking JARDIANCE and may lead
to hospitalization. Tell your healthcare provider 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.
-
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 heartbeat
- sweating
- shaking or feeling jittery
- Necrotizing fasciitis. A rare but serious bacterial
infection that causes damage to the tissue under the skin in the
area between and around your anus and genitals
(perineum). This bacterial infection has happened in women
and men who take JARDIANCE, and may lead to hospitalization,
multiple surgeries, and death. Seek medical attention
immediately if you have fever or are feeling very weak, tired or
uncomfortable (malaise), and you develop any of the following
symptoms in the area between and around your anus and genitals:
pain or tenderness, swelling, and redness of skin
(erythema).
-
Vaginal yeast infection. Talk to
your healthcare provider if you have 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. Swelling of an uncircumcised penis may develop that
makes it difficult to pull back the skin around the tip of the
penis. Talk to your healthcare provider if you have
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.
Talk to your healthcare
provider about what to do if you get symptoms of a yeast infection
of the vagina or penis. Your healthcare provider may suggest
you use an over-the-counter antifungal medicine. Talk to your
healthcare provider right away if you use an over-the-counter
antifungal medication and your symptoms do not go away.
- Allergic (hypersensitivity)
reactions. Symptoms of serious allergic reactions to
JARDIANCE may include:
-
- swelling of your face, lips, throat, and other areas of your
skin
- difficulty with swallowing or breathing
- raised, red areas on your skin (hives)
If you have any of these
symptoms, stop taking JARDIANCE and contact your healthcare
provider or go to the
nearest emergency room right away.
The most common side effects of JARDIANCE include urinary tract infections and yeast infections in
females.
These are not all the possible side effects of JARDIANCE. For more information, ask your healthcare
provider or pharmacist.
Before taking JARDIANCE, tell your healthcare
provider about all of your medical conditions, including
if you:
- have kidney problems
- have liver problems
- have a history of infection of the vagina or penis
- have a history of urinary tract infections or problems with
urination
- are going to have surgery. Your healthcare provider may stop
your JARDIANCE before you have surgery. Talk to your healthcare
provider if you are having surgery about when to stop taking
JARDIANCE and when to start it again
- are eating less or there is 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 type 1 diabetes. JARDIANCE should not be used to treat
people with type 1 diabetes
- are pregnant or plan to become pregnant. JARDIANCE may harm
your unborn baby. Tell your healthcare provider right away if you
become pregnant during treatment with JARDIANCE
- are breastfeeding or are planning to breastfeed. JARDIANCE may
pass into your breast milk and may harm your baby. Do not
breastfeed while taking JARDIANCE
Tell your healthcare
provider about all the medicines you take,
including prescription and over-the-counter medicines,
vitamins, and herbal supplements. Especially tell
your healthcare provider if you take
water pills
(diuretics) or medicines that can lower your blood sugar, such
as insulin.
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 and
Medication Guide.
CL-JAR-100093 08.18.2021
Prioritizing Cardio-Renal-Metabolic Care
Through
research and educational initiatives, Boehringer Ingelheim and
Lilly are driven to redefine care for people with
cardio-renal-metabolic conditions, a group of interconnected
disorders that affect more than one billion people worldwide and
are a leading cause of death.
The cardiovascular, renal (kidney) and metabolic systems are
closely intertwined and share many of the same disease-related
pathways. Dysfunction in one system may accelerate the onset of
dysfunction in others, resulting in the progression of comorbid
diseases such as type 2 diabetes, heart failure and chronic kidney
disease. Conversely, improving the health of one system can lead to
positive effects across the others and can help reduce the risk for
further complications.
Understanding their interconnected nature, we are working to
advance treatments for people with cardio-renal-metabolic
conditions. It is only through a holistic approach to care that we
can truly transform outcomes and restore the harmony among these
critical systems.
Boehringer Ingelheim and Eli Lilly and Company
In
January 2011, Boehringer Ingelheim
and Eli Lilly and Company announced an alliance that centers on
compounds representing several of the largest diabetes treatment
classes. Depending on geographies, the companies either co-promote
or separately promote the respective molecules each contributing to
the alliance. The alliance leverages the strengths of two of the
world's leading pharmaceutical companies to focus on patient needs.
By joining forces, the companies demonstrate their commitment, not
only to the care of people with diabetes, but also to investigating
the potential to address areas of unmet medical need.
About Boehringer Ingelheim
Making new and better
medicines for humans and animals is at the heart of what we do. Our
mission is to create breakthrough therapies that change lives.
Since its founding in 1885, Boehringer Ingelheim is independent and
family-owned. We have the freedom to pursue our long-term vision,
looking ahead to identify the health challenges of the future and
targeting those areas of need where we can do the most good.
As a world-leading, research-driven pharmaceutical company, with
around 52,000 employees, we create value through innovation daily
for our three business areas: Human Pharma, Animal Health, and
Biopharmaceutical Contract Manufacturing. In 2020, Boehringer
Ingelheim achieved net sales of around 22.33
billion USD (19.57 billion
EUR). Our significant investment of over 4.2 billion USD (3.7
billion EUR) in 2020 (18.9% of net sales) in R&D drives
innovation, enabling the next generation of medicines that save
lives and improve quality of life.
We realize more scientific opportunities by embracing the power
of partnership and diversity of experts across the life-science
community. By working together, we accelerate the delivery of the
next medical breakthrough that will transform the lives of patients
now, and in generations to come.
Boehringer Ingelheim Pharmaceuticals, Inc., based in
Ridgefield, CT, is the largest
U.S. subsidiary of Boehringer Ingelheim Corporation and is part of
the Boehringer Ingelheim group of companies. In addition, there are
Boehringer Ingelheim Animal Health in Duluth, GA and Boehringer Ingelheim Fremont,
Inc. in Fremont, CA.
Boehringer Ingelheim is committed to improving lives and
strengthening our communities. Please visit
www.boehringer-ingelheim.us/csr to learn more about Corporate
Social Responsibility initiatives.
For more information, please visit www.boehringer-ingelheim.us,
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, collaboration and quality
manufacturing we strive to make life better for people affected by
diabetes and related conditions. We work to deliver breakthrough
outcomes through innovative solutions—from medicines and
technologies to support programs and more. For the latest updates,
visit http://www.lillydiabetes.com/ or follow us on Twitter:
@LillyDiabetes and Facebook: LillyDiabetesUS.
About Eli Lilly and Company
Lilly is a global health care leader that unites caring with
discovery to create medicines that 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 lilly.com and lilly.com/newsroom.
This press release contains forward-looking statements (as
that term is defined in the Private Securities Litigation Reform
Act of 1995) about Jardiance and reflects Lilly's current belief.
However, as with any pharmaceutical product, there are substantial
risks and uncertainties in the process of drug 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 Jardiance will receive additional regulatory
approvals. For a further discussion of these and other risks and
uncertainties that could cause actual results to differ from
Lilly's expectations, please see Lilly's most recent Forms 10-K and
10-Q filed with the U.S. Securities and Exchange Commission. Lilly
undertakes no duty to update forward-looking statements.
Jardiance®, EMPEROR-Reduced® and
EMPEROR-Preserved® are registered trademarks of
Boehringer Ingelheim.
P-LLY
MPR-US-101873
CONTACTS:
Jennifer
Forsyth
Director, Public Relations
Boehringer Ingelheim Pharmaceuticals, Inc.
Email: jennifer.forsyth@boehringer-ingelheim.com
Phone: (203) 791-5889
Stephan Thalen
Global
Business Communications
Lilly Diabetes and Lilly USA
Email: stephan.thalen@lilly.com
Phone: (317) 903-5640
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