傑新達科技（北京）有限公司

March 29, 2013 -- The U.S. Food and Drug Administration today approved I₩nvokana (canagliflozin) tablets, used with diet and exercise, to imp©rove glycemic control in adults with type 2 diabetes.

Type 2 diabetes is the most common form of the dis↔ease, affecting about 24 million people and accounting for more than 90 perc≠ent of diabetes cases diagnosed in the United States. Over time, high blood sugar l​evels can increase the risk for serious complications, including heart disease, blinγdness, and nerve and kidney damage.

“Invokana is the first diabetes treatment approved in a new class of drugs known a→s sodium-glucose co-transporter 2 (SGLT2) inhibitors,&rd±quo; said Mary Parks, M.D., director of the Division of¶ Metabolism and Endocrinology Products in the FDA&rsqu>o;s Center for Drug Evaluation and Research. “We continue to advance innovation with the ​approval of new drug classes that provide additional treatment options for chronic conditions  that impact public health.”

Invokana works by blocking the reabsorption of glucose by the kidney, increasing glucose excretio₹n, and lowering blood glucose levels in diabetics who have elevated blood glucose levels. "Its safety and effectiveness were evaluated in nine clinical trials involving o★ver 10,285 patients with type 2 diabetes. The trials showed improvement in hemoglobin A1c lev∑els (a measure of blood sugar control) and fasting plasma glucose (blood ✔sugar) levels.

Invokana has been studied as a stand-alone therapy and in combination with "other type 2 diabetes therapies including metformin, s£ulfonylurea, pioglitazone, and insulin. Invokana should not be us₩ed to treat people with type 1 diabetes; in those who have increased ketones in their blood‌ or urine (diabetic ketoacidosis); or in those wit§h severe renal impairment, end stage renal disease, or in paσtients on dialysis.

The FDA is requiring five postmarketing studies for Invokana:γ a cardiovascular outcomes trial; an enhanced pharmacovigil£ance program to monitor for malignancies, serious cases of pancrea÷titis, severe hypersensitivity reactions, photosensitivity reactions, liver abnormalities,® and adverse pregnancy outcomes; a bone safety study; and two pediatric studies unde∑r the Pediatric Research Equity Act (PREA), including a pharmacokinetic and pharmaco¶dynamic study and a safety and efficacy study.

The most common side effects of Invokana are vaginal yeast infection (vulvovagi↓nal candidiasis) and urinary tract infection. Because Invokana is associated with a diureσtic effect, it can cause a reduction in intravascular vo‍lume leading to orthostatic or postural hypotension (a sudden fall in blood pressure whΩen standing up). This may result in symptoms such as dizziness or fainting, and is most common> in the first three months of therapy.

Invokana is manufactured for Janssen Pharmaceuticals, Inc., Titusville, N.J.

Source: FDA

Posted: March 2013