Janssen Pharmaceuticals has announced the FDA ( Food and Drug Administration ) has approved Invokana ( Canagliflozin ) for the treatment of adults with type 2 diabetes.
Invokana is the first in a new class of medications called sodium glucose co-transporter 2 ( SGLT2 ) inhibitors to be approved in the United States. It is also the only oral, once-daily medication available in the United States offering improved glycemic control while also showing reduced body weight and systolic blood pressure in clinical trials.
Canagliflozin is thought to work differently than other currently-available medicines because it reduces blood glucose by acting on the kidneys as a glucuretic, increasing the loss of glucose in the urine.
The kidneys make an important contribution to balancing blood glucose. As glucose is filtered from the blood into the kidneys, it is reabsorbed back into the bloodstream. An important carrier responsible for this reabsorption is called sodium glucose co-transporter 2 ( SGLT2 ). Canagliflozin selectively inhibits SGLT2, and as a result promotes the loss of glucose in the urine, lowering blood glucose levels in adults with type 2 diabetes.
Invokana is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. Invokana has been studied as a single agent ( monotherapy ), in combination with Metformin, and in combination with other glucose-lowering agents, including Insulin, in patients who need further glucose control.
Results from the phase 3 studies showed Invokana was generally well tolerated. The most common adverse events with Invokana are 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.
Overall the rate of discontinuation due to adverse events was 4.3% for the Invokana starting dose of 100 mg, 3.6% for Invokana 300 mg and 3.1% versus competitors.
The new drug application for Invokana was based on a comprehensive global phase 3 clinical program, which enrolled 10,285 patients in 9 studies.
Results from this program showed that the 100 mg and the 300 mg doses of Invokana improved glycemic control and, in prespecified secondary endpoints, were associated with significant reductions in body weight and systolic blood pressure.
In two studies comparing Invokana to current standard treatments - 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.
In the two studies, the overall incidence of adverse events was similar with Invokana and the comparators.
In studies of Invokana as monotherapy or in combination with agents not associated with hypoglycemia ( such as Metformin or Metformin and Pioglitazone ), the incidence of hypoglycemic episodes were less than 5% across the groups ( Invokana 100 mg [ 3.8% ], Invokana 300 mg [ 4.3% ], and placebo [ 2.2% ] ). There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with Invokana or any other antidiabetic medication. Additional data are being collected to further characterize the cardiovascular profile of Invokana.
The Centers for Disease Control and Prevention ( CDC ) estimates that nearly 26 million Americans have diabetes, 90 to 95% of which is type 2 diabetes.
U.S. national data from 2007 to 2010 show that nearly half of adults with type 2 diabetes were not achieving recommended levels of glucose control.
Approximately 60% of patients with type 2 diabetes in the United States are obese, while another 30% are overweight. In most people at risk for type 2 diabetes, obesity causes the body to resist the action of insulin, and if the pancreatic beta cell cannot produce enough insulin, hyperglycemia and type 2 diabetes ensue. If left uncontrolled, type 2 diabetes can lead to serious complications; improved glycemic control has been demonstrated to reduce the onset and progression of these complications.
Important information about Invokana
Invokana can cause some people to have dehydration. Dehydration may cause you to feel dizzy, faint, lightheaded, or weak, especially when he/she stands up ( orthostatic hypotension ).
The patient may be at higher risk of dehydration if he/she: has low blood pressure; takes medicines to lower your blood pressure, including diuretics; is on low sodium diet; has kidney problems; is 65 years of age or older.
Women who take Invokana may get vaginal yeast infections. Symptoms of a vaginal yeast infection include: vaginal odor, white or yellowish vaginal discharge ( discharge may be lumpy or look like cottage cheese ), vaginal itching.
Men who take Invokana may get a yeast infection of the skin around the penis ( balanitis or balanoposthitis ). Certain men who are not circumcised may have swelling of the penis that makes it difficult to pull back the skin around the tip of the penis. Other symptoms of yeast infection of the penis include: redness, itching, or swelling of the penis; rash of the penis; foul smelling discharge from the penis; pain in the skin around penis.
Invokana is contraindicated in people with allergies to Canagliflozin or any of the ingredients in Invokana. Symptoms of allergic reaction to Invokana may include: rash; raised red patches on your skin ( hives ); swelling of the face, lips, tongue, and throat that may cause difficulty in breathing or swallowing; severe kidney problems or on dialysis.
Invokana may affect the way other medicines work, and other medicines may affect how Invokana works, especially if the patient takes: diuretics, Rifampin ( used to treat or prevent tuberculosis ), Phenytoin or Phenobarbital ( used to control seizures ), Ritonavir ( Norvir, Kaletra, Lopinavir ) ( used to treat HIV infection ), Digoxin ( Lanoxin ) ( used to treat heart problems ).
Invokana may cause serious side effects, including: kidney problems, hyperkalemia, hypoglycemia.
Invokana associated with another medicine that can cause low blood sugar, such as a sulfonylurea or Insulin, may increase hyperglycemia. The dose of sulfonylurea medicine or Insulin may need to be lowered while the patient is taking Invokana. Signs and symptoms of low blood sugar may include: headache, drowsiness, weakness, dizziness, confusion, irritabilità, hunger, fast heart-beat, sweating, shaking or feeling jittery, serious allergic reaction.
The most common side effects of Invokana include: vaginal yeast infections and yeast infections of the penis; urinary tract infection, changes in urination, including urgent need to urinate more often, in larger amounts, or at night. ( Xagena )
Source: Janssen Pharmaceuticals, 2013