National Kidney Foundation Honors Janssen Pharmaceutical Companies of Johnson & Johnson with 2020 Corporate Innovator Award

Company recognized for developing the first new treatment for diabetic kidney disease (DKD) to be approved by the FDA in nearly two decades.

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National Kidney Foundation

Mar 20, 2020, 09:29 ET

NEW YORK, March 20, 2020 /PRNewswire/ -- Janssen Pharmaceuticals Inc., part of the Janssen Pharmaceutical Companies of Johnson & Johnson has been selected to receive the 2020 Corporate Innovator Award from the National Kidney Foundation (NKF) as part of the annual Spring Clinical Meetings.

In September 2019, Janssen's INVOKANA^® (canagliflozin) was approved by the U.S. Food and Drug Administration (FDA) to reduce the risk of end-stage kidney disease (ESKD),worsening of kidney function, cardiovascular (CV) death, and hospitalization for heart failure in adults with type 2 diabetes and diabetic kidney disease (DKD) with a certain amount of protein in the urine.

"Diabetes is a key risk factor for DKD, and accounts for 44 percent of all end-stage kidney disease cases," said Kevin Longino, CEO of NKF and a kidney transplant patient. "However, less than 40 percent of those with diabetes are completely assessed for kidney disease. The National Kidney Foundation applauds Janssen for bringing forth this treatment and urges patients living with type 2 diabetes to discuss the implications of this option with their healthcare provider."

Diabetes and DKD are common and complex disorders, which often co-exist, and each are associated with multiple comorbid conditions and higher risk for mortality. SGLT2s are proteins found in the kidneys that are important in the reabsorption of glucose by the kidneys. INVOKANA^®, a SGLT2 inhibitor that has been used for glycemic control in people with type 2 diabetes by inhibiting renal reabsorption of glucose, has now been shown to slow the progression of DKD and reduce the risk of hospitalization for heart failure in this population.

This year's Spring Clinical Meetings will be a Live-Virtual Meeting due to the COVID-19 outbreak. This necessary change will help ensure the safety of our patients, staff, volunteers and conference participants while still enabling NKF to provide the high-quality content SCM is known for in a new live-virtual format.

The Corporate Innovator Award was established to recognize industry leaders that advance the field of nephrology by addressing an unmet medical need, or improving upon an existing practice, therapeutic or technology.

NKF Spring Clinical Meetings

For the past 28 years, nephrology healthcare professionals from across the country have come to NKF's Spring Clinical Meetings to learn about the newest developments related to all aspects of nephrology practice; network with colleagues; and present their research findings. The NKF Spring Clinical Meetings are designed for meaningful change in the multidisciplinary healthcare teams' skills, performance, and patient health outcomes. It is the only conference of its kind that focuses on translating science into practice for the entire healthcare team. This year's Spring Clinical Meetings will be a Live-Virtual Meeting due to the COVID-19 outbreak.

Kidney Disease Facts

In the United States 37 million adults are estimated to have chronic kidney disease—and more than 90 percent aren't aware of it. 1 in 3 American adults are at risk for chronic kidney disease. Risk factors for kidney disease include diabetes, high blood pressure, heart disease, obesity and family history. People of African American, Hispanic, Native American, Asian or Pacific Islander descent are at increased risk for developing the disease. African Americans are 3 times more likely than Whites, and Hispanics are nearly 1.5 times more likely than non-Hispanics to develop end stage renal disease (kidney failure).

The National Kidney Foundation (NKF) is the largest, most comprehensive and longstanding organization dedicated to the awareness, prevention and treatment of kidney disease. For more information about NKF visit www.kidney.org.

WHAT IS INVOKANA^®?

INVOKANA^® is a prescription medicine used:

along with diet and exercise to lower blood sugar (glucose) in adults with type 2 diabetes
to reduce the risk of major cardiovascular events such as heart attack, stroke, or death in adults with type 2 diabetes who have known cardiovascular disease
to reduce the risk of end-stage kidney disease (ESKD), worsening of kidney function, cardiovascular death, and hospitalization for heart failure in adults with type 2 diabetes mellitus and diabetic kidney disease (nephropathy) with a certain amount of protein in the urine

INVOKANA^® is not for people with type 1 diabetes or with diabetic ketoacidosis (increased ketones in blood or urine). It is not known if INVOKANA^® is safe and effective in children under 18 years of age.
IMPORTANT SAFETY INFORMATION
INVOKANA^® can cause important side effects, including:

Amputations. INVOKANA^® may increase your risk of lower-limb amputations. Amputations mainly involve removal of the toe or part of the foot; however, amputations involving the leg, below and above the knee, have also occurred. Some people had more than one amputation, some on both sides of the body. You may be at a higher risk of lower-limb amputation if you: have a history of amputation, have heart disease or are at risk for heart disease, have had blocked or narrowed blood vessels (usually in leg), have damage to the nerves (neuropathy) in the leg, or have had diabetic foot ulcers or sores. Call your doctor right away if you have new pain or tenderness, any sores, ulcers, or infections in your leg or foot. Your doctor may decide to stop your INVOKANA^® for a while if you have any of these signs or symptoms. Talk to your doctor about proper foot care
Dehydration. INVOKANA^® can cause some people to become dehydrated (the loss of too much body water), which may cause you to feel dizzy, faint, lightheaded, or weak, especially when you stand up (orthostatic hypotension). You may be at higher risk of dehydration if you have low blood pressure, take medicines to lower your blood pressure (including diuretics [water pills]), are on a low sodium (salt) diet, have kidney problems, or are 65 years of age or older. Talk to your doctor about what you can do to prevent dehydration including how much fluid you should drink on a daily basis
Vaginal yeast infection. Women who take INVOKANA^® may get vaginal yeast infections. Symptoms include: vaginal odor, white or yellowish vaginal discharge (discharge may be lumpy or look like cottage cheese), or vaginal itching
Yeast infection of the penis (balanitis or balanoposthitis). Men who take INVOKANA^® may get a yeast infection of the skin around the penis. Symptoms include: redness, itching, or swelling of the penis; rash of the penis; foul-smelling discharge from the penis; or pain in the skin around penis

Talk to your doctor about what to do if you get symptoms of a yeast infection of the vagina or penis.
Do not take INVOKANA^® if you:

are allergic to canagliflozin or any of the ingredients in INVOKANA^®. Symptoms of allergic reaction may include: rash; raised red patches on your skin (hives); or swelling of the face, lips, mouth, tongue, and throat that may cause difficulty in breathing or swallowing
have severe kidney problems and are taking INVOKANA^®to lower your blood sugar
are on kidney dialysis

Before you take INVOKANA^®, tell your doctor if you have a history of amputation; heart disease or are at risk for heart disease; blocked or narrowed blood vessels (usually in leg); damage to the nerves (neuropathy) of your leg; diabetic foot ulcers or sores; kidney problems; liver problems; history of urinary tract infections or problems with urination; are on a low sodium (salt) diet; are going to have surgery (your doctor may stop your INVOKANA^® before you have surgery; talk to your doctor if you are having surgery about when to stop taking INVOKANA^® and when to start it again); are eating less, or there is a change in diet; pancreas problems; drink alcohol very often (or drink a lot of alcohol in short-term); ever had an allergic reaction to INVOKANA^®; or have other medical conditions.
Tell your doctor if you are or plan to become pregnant, are breastfeeding, or plan to breastfeed. INVOKANA^® may harm your unborn baby. If you become pregnant while taking INVOKANA^®, tell your doctor right away. INVOKANA^® may pass into your breast milk and may harm your baby. Do not breastfeed while taking INVOKANA^®.
Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take diuretics (water pills), rifampin (used to treat or prevent tuberculosis), phenytoin or phenobarbital (used to control seizures), ritonavir (Norvir^®, Kaletra^®– used to treat HIV infection), or digoxin (Lanoxin^®– used to treat heart problems).
Possible Side Effects of INVOKANA^®INVOKANA^® may cause serious side effects, including:

Ketoacidosis (increased ketones in your blood or urine). Ketoacidosis has happened in people who have type 1 or type 2 diabetes, during treatment with INVOKANA^®. Ketoacidosis has also happened in people with diabetes who were sick or who had surgery during treatment with INVOKANA^®. Ketoacidosis is a serious condition, which may need to be treated in a hospital. Ketoacidosis may lead to death. Ketoacidosis can happen with INVOKANA^® even if your blood sugar is less than 250 mg/dL. Stop taking INVOKANA^® and call your doctor right away if you get any of the following symptoms: nausea, vomiting, stomach-area pain, tiredness, or trouble breathing
Kidney problems. Sudden kidney injury has happened to people taking INVOKANA^®. Talk to your doctor right away if you: 1) reduce the amount of food or liquid you drink, if you are sick, or cannot eat or 2) you start to lose liquids from your body from vomiting, diarrhea, or being in the sun too long
Serious Urinary Tract Infections: may lead to hospitalization and have happened in people taking INVOKANA^®. Tell your doctor if you have signs or symptoms of a urinary tract infection such as: burning feeling while urinating, need to urinate often or right away, pain in the lower part of your stomach (pelvis), or blood in the urine. Some people may also have high fever, back pain, nausea, or vomiting
Low blood sugar (hypoglycemia). If you take INVOKANA^® 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 medicine or insulin may need to be lowered while you take INVOKANA^®. Signs and symptoms of low blood sugar may include: headache, drowsiness, weakness, dizziness, confusion, irritability, hunger, fast heartbeat, sweating, shaking, or feeling jittery
A rare but serious bacterial infection that destroys the tissue under the skin (necrotizing fasciitis) in the area between and around the anus and genitals (perineum). Necrotizing fasciitis of the perineum has happened in women and men who take INVOKANA^®. Necrotizing fasciitis of the perineum may lead to hospitalization, may require multiple surgeries, and may lead to death. Seek medical attention immediately if you have fever or you 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, or redness of the skin (erythema)
Serious allergic reaction. If you have any symptoms of a serious allergic reaction, stop taking INVOKANA^® and call your doctor right away or go to the nearest hospital emergency room
Broken Bones (fractures): Bone fractures have been seen in patients taking INVOKANA^®. Talk to your doctor about factors that may increase your risk of bone fracture

The most common side effects of INVOKANA^® include: vaginal yeast infections and yeast infections of the penis; changes in urination, including urgent need to urinate more often, in larger amounts, or at night.
Tell your doctor if you have any side effect that bothers you or that does not go away. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Janssen Scientific Affairs, LLC at 1-800-526-7736.
Please click here for full Product Information, including Boxed Warning, and Medication Guide for INVOKANA^®.
Canagliflozin is licensed from Mitsubishi Tanabe Pharma Corporation.
Trademarks are those of their respective owners.

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SOURCE National Kidney Foundation