The supplemental New Drug Application is based
on results from the landmark EMPA-KIDNEY phase III trial, which
showed Jardiance® (empagliflozin) tablets significantly reduced the
risk of kidney disease progression* or cardiovascular death in
adults with CKD by 28% (absolute risk reduction [ARR]: 3.8%)
compared with placebo, both on top of standard of care.
RIDGEFIELD, Conn. and INDIANAPOLIS, Jan. 20,
2023 /PRNewswire/ -- The U.S. Food and Drug
Administration (FDA) has accepted a supplemental New Drug
Application (sNDA) for Jardiance® (empagliflozin)
tablets, which is being investigated as a potential treatment to
reduce the risk of kidney disease progression and cardiovascular
death in adults with chronic kidney disease (CKD), Boehringer
Ingelheim and Eli Lilly and Company (NYSE: LLY) announced.
"There is a significant need for additional therapies that
reduce the risk of kidney disease progression and hospitalizations
in adults with CKD," said Mohamed
Eid, M.D., M.P.H., M.H.A., vice president, Clinical
Development & Medical Affairs, Cardio-Renal-Metabolism &
Respiratory Medicine, Boehringer Ingelheim Pharmaceuticals, Inc.
"This application acceptance is an important step forward for the
approximately 37 million people in the U.S. living with CKD."
The sNDA is based on results from the landmark EMPA-KIDNEY phase
III trial, in which Jardiance significantly reduced the risk of
kidney disease progression* or cardiovascular death in adults with
CKD by 28% (ARR: 3.8%) compared with placebo, both on top of
standard of care. Results were presented during the American
Society of Nephrology (ASN)'s Kidney Week 2022 and
simultaneously published in The New England Journal of
Medicine. EMPA-KIDNEY is the first SGLT2 inhibitor CKD
trial to show a significant reduction in risk of
hospitalization for any cause, with a 14% relative risk reduction
with Jardiance versus placebo (24.8 vs. 29.2 events/100
patient-years, respectively), both on top of standard of
care, in a pre-specified key secondary endpoint.
Reductions in other key secondary endpoints of hospitalization for
heart failure or cardiovascular death or all-cause death were not
statistically significant. Hospitalizations account for 35% to 55%
of total healthcare costs for people with CKD in the U.S.
EMPA-KIDNEY, the largest and broadest dedicated SGLT2 inhibitor
trial in CKD to date, provides additional data for patients
commonly seen in clinical practice. The trial enrolled 6,609
participants, including people without diabetes (56%), those with
various underlying causes of CKD and those across the spectrum of
eGFR and urine albumin-creatinine ratio (measures of kidney
function and excess albumin in the urine, respectively). Overall,
the safety data in EMPA-KIDNEY were consistent with the previously
known safety profile of Jardiance.
Initially approved in 2014, Jardiance is a once-daily tablet
used along with diet and exercise to lower blood sugar in adults
with type 2 diabetes; and to reduce the risk of cardiovascular
death in adults with type 2 diabetes and known cardiovascular
disease. Jardiance is also indicated to reduce the risk of
cardiovascular death and hospitalization for heart failure in
adults with heart failure. Jardiance is not for patients with type
1 diabetes, or to improve glycemic control in adults with type 2
diabetes with an eGFR <30 mL/min/1.73
m2. 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.
"This marks another exciting milestone for Jardiance,
potentially extending its ability to positively impact the
approximately one billion people diagnosed with a cardio, renal or
metabolic condition," said Jeff
Emmick, M.D., Ph.D., vice president, Product Development,
Lilly. "We look forward to working with the FDA during the review
process and eagerly await a decision later this year on the
indication for CKD, which doubles a person's risk for
hospitalization."
In March 2020, the FDA granted
Fast Track designation to the clinical investigation of Jardiance
to reduce the risk of kidney disease progression and cardiovascular
death in adults with CKD. According to the FDA, Fast Track
designation is designed to facilitate the development of drugs and
expedite treatments that may address serious conditions and fill an
unmet medical need. Jardiance is not indicated for the treatment of
CKD.
*Kidney disease progression: Defined as end-stage kidney
disease (the initiation of maintenance dialysis or receipt of a
kidney transplant), a sustained decline in estimated glomerular
filtration rate (eGFR) to below 10 mL/min/1.73 m2, kidney death or a sustained
decline of at least 40% in eGFR from randomization).
About EMPA-KIDNEY: The study of heart and kidney protection
with Jardiance
EMPA-KIDNEY (NCT03594110) is a multinational, randomized,
double-blind, placebo-controlled clinical trial, designed to
evaluate the effect of Jardiance on kidney disease progression and
cardiovascular mortality risk. The primary outcome is defined as
time to a first event of either cardiovascular death or kidney
disease progression, defined as end-stage kidney disease (the need
for kidney replacement therapy such as dialysis or kidney
transplantation), a sustained decline in eGFR to <10
mL/min/1.73 m2, kidney
death or a sustained decline of ≥40 percent in eGFR from
randomization. Key secondary outcomes include cardiovascular death
or hospitalization for heart failure, all-cause hospitalization and
all-cause mortality. EMPA-KIDNEY includes 6,609 adults randomized
from eight countries with established CKD both with and without
diabetes, as well as with and without albuminuria, receiving either
Jardiance 10 mg or placebo, on top of current standard of
care.
What is JARDIANCE?
JARDIANCE is a prescription medicine used to:
- reduce the risk of cardiovascular death and hospitalization for
heart failure in adults with heart failure, when the heart cannot
pump enough blood to the rest of your body
- reduce the risk of cardiovascular death in adults with type 2
diabetes who also have known cardiovascular disease
- lower blood sugar along with diet and exercise in adults with
type 2 diabetes
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 a 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
JARDIANCE before you have surgery. Talk to your healthcare provider
about when to stop taking JARDIANCE if you are having surgery 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.
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-100131 10.17.2022
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
Boehringer Ingelheim is working on breakthrough therapies that
improve the lives of humans and animals. As a leading
research-driven biopharmaceutical company, the company creates
value through innovation in areas of high unmet medical need.
Founded in 1885 and family-owned ever since, Boehringer Ingelheim
takes a long-term perspective. Around 52,000 employees serve more
than 130 markets in the three business areas, Human Pharma, Animal
Health, and Biopharmaceutical Contract Manufacturing. Learn more
at www.boehringer-ingelheim.us.
About Lilly
Lilly unites caring with discovery to
create medicines that make life better for people around the world.
We've been pioneering life-changing discoveries for nearly 150
years, and today our medicines help more than 47 million
people across the globe. Harnessing the power of biotechnology,
chemistry and genetic medicine, our scientists are urgently
advancing new discoveries to solve some of the world's most
significant health challenges, redefining diabetes care, treating
obesity and curtailing its most devastating long-term effects,
advancing the fight against Alzheimer's disease, providing
solutions to some of the most debilitating immune system disorders,
and transforming the most difficult-to-treat cancers into
manageable diseases. With each step toward a healthier world, we're
motivated by one thing: making life better for millions more
people. That includes delivering innovative clinical trials that
reflect the diversity of our world and working to ensure our
medicines are accessible and affordable. To learn more,
visit Lilly.com and Lilly.com/newsroom or
follow us on Facebook, Instagram and LinkedIn.
This press release contains forward-looking statements (as
that term is defined in the Private Securities Litigation Reform
Act of 1995) about Jardiance® as a treatment for adults with type 2
diabetes, to reduce the risk of cardiovascular death in adults with
type 2 diabetes and known cardiovascular disease, and to reduce the
risk of cardiovascular death and hospitalization for heart failure
in adults with heart failure, and as a potential treatment for
adults with cardio-kidney-metabolic conditions and reflects Lilly's
current beliefs and expectations. However, as with any
pharmaceutical product, there are substantial risks and
uncertainties in the process of drug research, development and
commercialization. Among other things, there can be no guarantee
that planned or ongoing studies will be completed as planned, 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®,
EMPEROR-Preserved®, EMPA-REG
OUTCOME® and EMPACT-MI® are
registered trademarks of Boehringer Ingelheim.
P-LLY
MPR-US-102395
CONTACTS:
Sheryl van der Hilst
Boehringer Ingelheim
Email: sheryl.van_der_hilst@boehringer-ingelheim.com
Phone: 914-772-7973
Kristiane Bello
Eli Lilly and Company
Email: bello_kristiane@lilly.com
Phone: (317) 315-9052
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SOURCE Eli Lilly and Company