US FDA grants Fast Track designation to Jardiance® for the treatment of chronic kidney disease
RIDGEFIELD, Conn. and INDIANAPOLIS,
"Chronic kidney disease can have a devastating impact on people's lives. Not only does it cause damage to the kidneys that can eventually lead to the need for dialysis or transplant, but it could also increase the risk of cardiovascular death," said
Chronic kidney disease is associated with an increased risk of premature death from cardiovascular causes and is the ninth leading cause of death in the
"We recognize the close link between the health of the heart, kidneys and metabolic system, and we have committed to a broad clinical development program assessing the cardiorenal metabolic benefits of Jardiance," said
The ongoing EMPA-KIDNEY clinical study is evaluating the effect of Jardiance on the progression of kidney disease and the occurrence of cardiovascular death in adults with established chronic kidney disease with and without diabetes. The EMPA-KIDNEY study was initiated based on promising exploratory results from the landmark EMPA-REG OUTCOME® trial, which found that treatment with Jardiance reduced the risk of new-onset and worsening kidney disease by 39 percent in adults with type 2 diabetes and established cardiovascular disease compared with placebo.
EMPA-KIDNEY is being independently conducted, analyzed and reported by the Medical Research Council Population Health Research Unit at the
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 not for people with type 1 diabetes or for people with diabetic ketoacidosis (increased ketones in the blood or urine).
About EMPA-KIDNEY [NCT03594110]
EMPA-KIDNEY is a multinational randomized, double-blind, placebo-controlled clinical trial. It is 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, renal death, or a sustained decline of ≥40% in eGFR from randomization. EMPA-KIDNEY includes adults with established chronic kidney disease both with and without diabetes.
The study is a global trial aiming to randomize about 6,000 participants to receive either Jardiance 10 mg once daily or placebo, each on top of standard of care.
About Chronic Kidney Disease
Chronic kidney disease is defined as a progressive decline of kidney function over time. About two-thirds of chronic kidney disease cases are attributable to metabolic diseases such as diabetes (known as diabetic kidney disease), hypertension and obesity. Notably, chronic kidney disease is associated with increased morbidity and mortality. The majority of deaths among people with chronic kidney disease occur as a result of cardiovascular complications, often before reaching end stage renal disease. Chronic kidney disease affects approximately 15 percent of adults in the United States and treatment costs are estimated to exceed $48 billion annually. Since there are currently only few treatment options, the overarching unmet medical need for additional treatment options in chronic kidney disease is evident.
About Cardiorenal Metabolic Conditions
Cardiorenal metabolic conditions are a group of interconnected disorders affecting the heart, kidneys and endocrine system. In aggregate, these conditions are the leading cause of deaths worldwide, accounting for up to 20 million deaths annually. Conditions within this group include coronary artery disease, heart failure, chronic kidney disease and type 2 diabetes, among many others.
Emerging science on the link between the cardiorenal and metabolic systems supports taking a multidisciplinary approach toward diagnostic, preventive and therapeutic strategies for people living with these conditions. We remain committed to developing treatments with broad cardiorenal metabolic effects, which may help improve outcomes for people with serious chronic conditions such as these.
What is JARDIANCE? (www.jardiance.com)
JARDIANCE is a prescription medicine used along with diet and exercise to lower blood sugar in adults with type 2 diabetes.
JARDIANCE is also used to reduce the risk of cardiovascular death in adults with type 2 diabetes who have known cardiovascular disease.
JARDIANCE is not for people with type 1 diabetes or for people with diabetic ketoacidosis (increased ketones in the blood or urine).
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 have severe kidney problems or are on dialysis.
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.
- Ketoacidosis (increased ketones in your blood or urine). Ketoacidosis is a serious condition and may need 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 doctor right away if you get any of the following symptoms, and if possible, check for ketones in your urine:
- stomach-area (abdominal) pain
- trouble breathing
- Kidney problems. Sudden kidney injury has happened in people taking JARDIANCE. Talk to your doctor right away if you reduce the amount you eat or drink, or if you lose liquids; for example, 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 doctor 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:
- fast heartbeat
- 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).
- 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 doctor or go to the nearest emergency room right away.
- Increased fats in your blood (cholesterol).
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 doctor or pharmacist.
Before taking 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
- are going to have surgery. Your doctor may stop your JARDIANCE before you have surgery. Talk to your doctor 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 any other medical conditions
- are pregnant or plan to become pregnant. JARDIANCE may harm your unborn baby. Tell your doctor 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 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.
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.
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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
Jardiance® and EMPA-REG OUTCOME® are registered trademarks of Boehringer Ingelheim.
Director, Public Relations
Phone: (203) 791-5889
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