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canagliflozin 35 articles

Europe approves new type 2 diabetes drug Invokana

European drug regulators have given the marketing green light to Invokana (canagliflozin), a new type of type 2 diabetes medication. The drug was approved by the U.S. Food and Drug Administration (FDA) in May and was the first in the U.S. and the second in Europe from a new class of medications known as sodium-glucose co-transporter 2 (SGLT2) inhibitors. SGLT2 inhibitors are designed to help reduce blood sugar levels by preventing the reabsorption of glucose from the kidneys back into the blood so that more glucose is excreted in the urine. Invokana is a once-daily treatment for adults with type ... Read More

Makers of new diabetes drug hope more data will help drug win FDA approval

Blood sugar levels were improved, body weight was reduced, and blood pressure was lowered in patients who were given a new type 2 diabetes drug, according to the drug’s makers, Bristol-Myers Squibb and AstraZeneca. The treatment, known as dapagliflozin, was pitted against a placebo in clinical trials in patients with type 2 diabetes who were also taking a combination of metformin plus sulfonylurea. Dapagliflozin is a once daily pill that was approved in the European Union under the brand name Forxiga last November. It is also sold in Australia, Brazil, Mexico and New Zealand. Dapagliflozin works by removing excess blood ... Read More

Experimental diabetes drug tied to heart attacks, strokes, death

An increased risk of heart attacks, strokes and deaths may hurt the chances of Johnson & Johnson’s experimental diabetes drug canagliflozin being approved by the Food and Drug Administration (FDA). Data from nine large patient studies showed the drug raised levels of LDL, or bad cholesterol, and slightly increased risk of cardiovascular events or death compared to two other types of diabetes medications. The drug was also tied to urinary tract infections and fungal infections in the genital area, likely because the drug works by increasing the amount of sugar excreted in the urine, and germs thrive on that sugar. ... Read More

Johnson and Johnson seeks FDA approval for new type 2 diabetes treatment

Johnson & Johnson’s Janssen Research & Development is hoping to win approval for its new type 2 diabetes treatment, a fixed-dose therapy combining canagliflozin and immediate release metformin. Canagliflozin is a selective sodium glucose co-transporter 2 (SGLT2) inhibitor that works by blocking the reabsorption of glucose by the kidney, increasing glucose excretion, and lowering blood glucose levels. Metformin, an older medication, is a biguanide that lowers blood glucose levels by decreasing the amount of glucose made by the liver. In its New Drug Application (NDA) to the Food and Drug Administration (FDA), Janssen provided data from the comprehensive global Phase ... Read More

FDA to review drugs in new class of type 2 diabetes medications

Two type 2 diabetes drugs in a new class of blood sugar lowering medications known as SGLT2 inhibitors are hoping to win approval from the Food and Drug Administration (FDA) – Johnson & Johnson’s canagliflozin, and empagliflozin, made jointly by Eli Lilly and Boehringer Ingelheim. The drug makers presented the benefits of their medications recently at the European Association for the Study of Diabetes meeting in Berlin. The two drugs are among several of their kind for the treatment of diabetes, and are in various stages of development. The FDA is currently reviewing data for canagliflozin, and it is expected ... Read More