Tagged Articles

Forxiga 7 articles

European regulators to review serious metabolic side effects with diabetes drugs

The European Medicines Agency (EMA) announced it will review the risk of a life threatening metabolic condition known as ketoacidosis from the use of certain type 2 diabetes drugs known as SGLT2 inhibitors. The review comes just after the U.S. Food and Drug Administration (FDA) ordered that warnings be placed on the labels of SGLT2 drugs advising patients and doctors of this risk. Ketoacidosis is a serious diabetes complication where the body produces excess blood acids, or ketones. It can lead to diabetic coma or death. It generally occurs when insulin levels are too low or during prolonged fasting. However, ... Read More

Japan approves new type 2 diabetes drug dapagliflozin

Japanese drug authorities have approved Forxiga (dapagliflozin) for the treatment of type 2 diabetes. Dapagliflozin, a sodium-glucose cotransporter 2 (SGLT-2) inhibitor, is a once-daily oral treatment that works independent of insulin to help remove excess glucose from the body. It is currently approved in more than 40 countries around the world, including the United States, where it is marketed under the brand name Farxiga. SGLT-2 inhibitors are a relatively new class of diabetes medications. It was the first of its kind to be approved in Europe, and the second, behind Johnson & Johnson’s Invokana, in the United States. The class ... Read More

Europe approves new combination diabetes treatment despite bladder cancer concerns

European drug regulators have approved AstraZeneca and Bristol-Myers Squibb’s combination type 2 diabetes drug Xigduo, making it the first treatment to combine a SGLT2 inhibitor with metformin. Xigduo is a combination of the widely used diabetes drug metformin and dapagliflozin, a new diabetes treatment sold in Europe as Forxiga. It was approved earlier this month by the U.S. Food and Drug Administration (FDA) under the name Farxiga. Dapagliflozin is in a new class of diabetes drugs known as SGLT2 inhibitors. Johnson & Johnson’s SGLT2 Invokana was approved in the U.S. in 2013. Other SGLT2 drugs are currently in development. The ... Read More

FDA approves new type 2 diabetes medication Farxiga

A new drug has been approved by the Food and Drug Administration (FDA) to help regulate blood sugar in patients with type 2 diabetes. Farxiga, developed by AstraZeneca and Bristol-Myers Squibb, has been available in Europe under the name Forxiga. U.S. drug regulators rejected the drug last year because of bladder cancer, heart disease and liver toxicity concerns. Farxiga is the second in a class of drugs known as SGLT2 inhibitors to be approved in the United States. Johnson & Johnson’s Invokana was approved earlier this year. Other drugmakers, including Boehringer Ingelheim, are also developing SGLT2 inhibitors. Drugs in this class ... Read More

FDA requests more data on diabetes drug candidate combining Invokana with metformin

The Food and Drug Administration (FDA) wants more clinical trial data on Janssen’s new type 2 diabetes treatment that combines the recently approved Invokana (canagliflozin) with the widely used metformin, before it will decide whether to approve the new combination therapy. The agency requested more information comparing the twice-daily combination pill with the once-daily canagliflozin. Janssen, a Johnson & Johnson company, says it has the data the agency needs from its comprehensive Phase 3 clinical development program for the drug. Canagliflozin was approved by the FDA in March 2013. It is the first approved drug in a new class of ... 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

Europe approves new diabetes drug despite bladder, breast cancer risks

European drug regulators have approved the experimental drug Forxiga, known by the generic name dapagliflozin, a once-daily pill for adult type 2 diabetes. It is the first drug approved in a new class of medications called SGLT2 inhibitors. The same drug was rejected in January by the U.S. Food and Drug Administration (FDA) because of concerns that the medication increased the risk of bladder cancer and breast cancer. Dapagliflozin works by increasing renal glucose elimination, thereby allowing more sugar to be excreted in the urine. During clinical trials nine out of 5,478 patients who were taking the drug were diagnosed ... Read More