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U.S. FDA Approves INVOKAMET(TM) (canagliflozin/metformin HCl) for the Treatment of Adults with Type 2 Diabetes

Companies mentioned in this article: Janssen Pharmaceuticals, Inc.

RARITAN, N.J., Aug. 8, 2014 /PRNewswire/ -- Janssen Pharmaceuticals, Inc. announced today the U.S. Food and Drug Administration (FDA) has approved INVOKAMET((TM)), a fixed-dose therapy combining canagliflozin and metformin hydrochloride in a single tablet, for the treatment of adults with type 2 diabetes. INVOKAMET((TM)) provides the clinical attributes of INVOKANA(®) (canagliflozin), the first sodium glucose co-transporter 2 (SGLT2) inhibitor available in the United States, together with metformin, which is commonly prescribed early in the treatment of type 2 diabetes. INVOKAMET((TM)) is the first fixed-dose combination of an SGLT2 inhibitor with metformin approved in the United States.

To view the multimedia assets associated with this release, please click: http://www.multivu.com/players/English/7288451-janssen-pharmaceuticals-fda-approved-invokamet-type-2-diabetes

"INVOKAMET((TM)) combines, in one tablet, two complementary therapeutic approaches proven effective for managing type 2 diabetes," said Richard Aguilar, M.D.*, Medical Director of Diabetes Nation. "Canagliflozin works with the kidney to promote the loss of glucose in the urine, whereas metformin decreases the production of glucose in the liver and improves the body's response to insulin."

INVOKAMET((TM)) is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus who are not adequately controlled by treatment that includes either canagliflozin or metformin, or who are already being treated with both canagliflozin and metformin as separate medications. INVOKAMET((TM)) should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis. Study results demonstrated that administration of INVOKAMET((TM)) was equivalent to co-administration of corresponding doses of canagliflozin and metformin as individual tablets.

INVOKAMET((TM)) will be available in tablets containing canagliflozin 50 milligrams (mg) or 150 mg, and metformin 500 mg or 1000 mg. The recommended dosing is twice daily. The prescribing information for INVOKAMET((TM)) also contains a boxed warning for lactic acidosis, a rare, but serious complication that can occur due to metformin accumulation.

"As with INVOKANA(®), INVOKAMET((TM)) provides adults with type 2 diabetes an oral therapy that lowers blood sugar and is also associated with reductions in body weight and systolic blood pressure," said Jimmy Ren, Ph.D., Therapeutic Area Lead, Metabolics, Medical Affairs, Janssen Pharmaceuticals, Inc. "The available doses of INVOKAMET((TM)) allow physicians to tailor therapy for individual patient needs and offer an alternative for patients who may be able to reduce the number of tablets they take each day."

In March 2013, the FDA approved canagliflozin -- INVOKANA(® )-- as a single agent, and it is the number-one branded non-insulin type 2 diabetes medication newly prescribed by U.S. endocrinologists.([1]) It is also the second most common branded therapy prescribed by primary care physicians when adding or switching therapies in patients.([2]) Since its launch, more than one million prescriptions have been written for INVOKANA(®).([3])

The co-administration of INVOKANA(®) and metformin has been studied in six Phase 3 clinical studies that enrolled 4,732 patients with type 2 diabetes. The Phase 3 studies evaluated INVOKANA(®) in combination with metformin compared to metformin alone or to metformin plus another diabetes therapy. The studies were part of the comprehensive global Phase 3 program for INVOKANA(® )that enrolled 10,285 patients, one of the largest clinical programs in type 2 diabetes submitted to health authorities to date. The Phase 3 studies showed that the combination of INVOKANA(®) and metformin lowered blood sugar and, in pre-specified secondary endpoints, was associated with significant reductions in body weight and systolic blood pressure.

In two studies comparing INVOKANA(®) plus metformin to current standard treatments plus metformin - one studying sitagliptin and the other studying glimepiride - INVOKANA(®) dosed at 300 mg provided greater reductions in A1C levels and body weight than either comparator. A1C is the percent of red blood cell hemoglobin with glucose attached to it and an indicator of average blood glucose over the previous two to three months. In the two studies, the overall incidence of adverse events was similar with INVOKANA(®) and the comparators.

Results from the Phase 3 studies showed that the most common adverse events with INVOKANA(®) are female genital mycotic (fungal) infections, urinary tract infections and increased urination. These specific adverse events were generally mild to moderate in intensity and infrequently led to discontinuation in Phase 3 studies. The most common adverse reactions due to initiation of metformin, as noted in the prescribing information for that medication, are diarrhea, nausea/vomiting, flatulence, asthenia, indigestion, abdominal discomfort, and headache. Hypoglycemia does not occur in patients receiving metformin alone under usual circumstances of use. INVOKANA(®) can increase the risk of hypoglycemia when combined with insulin or a medication that increases insulin levels (e.g., a sulfonylurea). Therefore, a lower dose of insulin or insulin-raising medication may be required to minimize the risk of hypoglycemia when used in combination with INVOKAMET((TM)).

Janssen Pharmaceuticals, Inc. and its affiliates have rights to canagliflozin through a license agreement with Mitsubishi Tanabe Pharma Corporation. Janssen Pharmaceuticals, Inc. and its affiliates have marketing rights in North America, South America, Europe, the Middle East, Africa, Australia, New Zealand and parts of Asia.

On April 25, 2014, Janssen-Cilag International NV announced that the European Commission (EC) approved VOKANAMET(®) (a fixed-dose therapy combining canagliflozin and immediate release metformin hydrochloride in a single tablet) in the European Union, for the treatment of adults with type 2 diabetes mellitus to improve glycemic control. INVOKANA(®) is approved as a single agent in Aruba, Australia, Brazil, Canada, Chile, Costa Rica, El Salvador, the European Union (31 countries), Guatemala, Kuwait, Mexico, Peru, Singapore, South Korea, Switzerland, United Arab Emirates, and the United States.

About Type 2 Diabetes

An estimated 371 million people worldwide are living with diabetes(([4])) and approximately 29 million people have diabetes in the United States.([5]) Type 2 diabetes comprises 90 to 95 percent of people with diabetes,([5]) which is chronic and affects the body's ability to metabolize sugar (glucose), and is characterized by the inability of pancreatic beta cell function to keep up with the body's demand for insulin.

Nearly half of adults with type 2 diabetes do not achieve recommended levels of glucose control, and if left uncontrolled, type 2 diabetes can lead to serious complications.(([6]))(,([7]),([8])) Improved glycemic control has been demonstrated to reduce the onset and progression of these complications.( ([9]))

WHAT IS INVOKAMET((TM))?

INVOKAMET((TM) )contains two prescription medicines called canagliflozin (INVOKANA(®)) and metformin hydrochloride (GLUCOPHAGE(®)). It is used along with diet and exercise to improve blood sugar (glucose) control in adults with type 2 diabetes when treatment with either canagliflozin or metformin, or both medications, has not controlled your blood sugar. INVOKAMET((TM)) is not for people with type 1 diabetes or with diabetic ketoacidosis (increased ketones in blood or urine). It is not known if INVOKAMET((TM)) is safe and effective in children under 18 years of age.

IMPORTANT SAFETY INFORMATION

INVOKAMET((TM)) can cause serious side effects, including: