FDA orders post-market studies on newly approved type 2 diabetes drug Jardiance

diabetes illus250x03 FDA orders post market studies on newly approved type 2 diabetes drug JardianceJardiance (empagliflozin), a new type 2 diabetes drug, has been granted approval by the U.S. Food and Drug Administration (FDA). The medication can be used alone or added to existing treatment regimens to control blood sugar levels.

Jardiance, made by Boehringer Ingelheim, is in a class of drugs called sodium glucose co-transporter 2 (SGLT2) inhibitors. These drugs work by stopping blood sugar from becoming reabsorbed by the kidneys. Thus, more glucose is excreted by the kidneys, which lowers blood sugar levels. Other SGLT2 drugs include Invokana (canagliflozin) and Farxiga (dapagliflozin).

The FDA approved Jardiance based on a review of seven clinical trials involving nearly 4,500 people with type 2 diabetes. The agency’s approval requires the drug maker to conduct post-marketing studies for any potential cardiovascular risks, as well as safety and effectiveness on children with type 2 diabetes.

The most common side effects with Jardiance are urinary tract infections and female genital infections. It can also impair kidney function. Some experts have raised questions about potential bladder cancer risks.

Many type 2 diabetes treatments have been linked to cancer. Studies have linked Actos to bladder cancer, and Januvia and Byetta have been associated with acute pancreatitis and pancreatic cancer.

In March, the FDA refused to approve Jardiance until Boehringer Ingelheim fixed deficiencies at one of its manufacturing plants. Last month, the drug won approval for marketing in the European Union.

Source: US News and World Report