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 2 diabetes who are unable to control their blood sugar levels through diet and exercise alone, or through the use of metformin. It is also approved as an add-on therapy with insulin and other glucose-lowering drugs.
Vaginal yeast infections and urinary tract infections were the most common side effects associated with Invokana, however the U.S. Food and Drug Administration (FDA) is requiring the drug maker to perform five postmarketing studies with Invokana including a cardiovascular outcomes trial, an enhanced pharmacovigilance program to monitor for malignancies; serious cases of pancreatitis, severe hypersensitivity reactions, photosensitivity reactions, liver abnormalities, and adverse pregnancy outcomes; and a bone safety study.
The FDA has begun taking a closer look at the risks posed by type 2 diabetes drugs since 2010, when the agency severely restricted the use of Avandia after it was linked to fatal heart attacks. A year later, the agency warned that studies showed that Actos put users at risk for bladder cancer. Recent studies have also shown that the drugs Januvia and Byetta can increase the risk of acute pancreatitis and pancreatic cancer.
The other SGLT2 inhibitor currently marketed in Europe is dapagliflozin, known by the brand name Forxiga. The drug was initially rejected by the FDA. The agency felt more information was required to assess the risk-benefit profile. The drug was resubmitted for U.S. approval and a decision is expected in January 2014.
Source: Diabetes UK