FDA Approves Jardiance - New Type 2 Diabetes Drug
FRIDAY, Aug. 1, 2014 -- The U.S. Food and Drug Administration announced on Friday that it approved a new drug, Jardiance, to help fight type 2 diabetes.
Jardiance (empagliflozin) "can be used alone or added to existing treatment regimens to control blood sugar levels in the overall management of diabetes," Dr. Curtis Rosebraugh, director of the Office of Drug Evaluation II in the FDA's Center for Drug Evaluation and Research, said in an agency statement.
The FDA also recommended that Jardiance be used along with lifestyle changes, such as eating a healthy diet and exercising regularly. The combination of medication and lifestyle modification may improve blood sugar management for people with type 2 diabetes, they said.
Over 26 million Americans are currently affected by type 2 diabetes, which accounts for about 90 percent of cases of diabetes, according to the agency.
Jardiance, made by Connecticut-based Boehringer Ingelheim Pharmaceuticals, falls into the class of diabetes medicines known as "sodium glucose co-transporter 2 (SGLT2) inhibitors." These drugs work by stopping blood sugar, or glucose, from getting reabsorbed by the kidneys. That means that more glucose is excreted by the kidneys and blood sugar levels go down, the FDA explained. Other drugs in this class of medications include Invokana (canagliflozin) and Farxiga (dapagliflozin).
The agency said the safety and effectiveness of Jardiance was tested in seven clinical trials involving almost 4,500 people with type 2 diabetes. The studies showed that Jardiance improved blood sugar levels compared to a "dummy" placebo drug.
The drug has also been studied for use alongside other medications, such as metformin, sulfonylureas, pioglitazone (Actos) and insulin. The FDA stressed that it is ordering post-marketing studies on Jardiance, with a focus on any potential cardiovascular effects, as well as safety and effectiveness in children.
Jardiance can trigger dehydration, which can cause low blood pressure, dizziness and impaired kidney function, the FDA added. This means that elderly people and those with already impaired kidney function may be at heightened risk when taking Jardiance. The drug should not be used by people with type 1 diabetes, according to the FDA.
The most common side effects seen with Jardiance included urinary tract infections and female genital infections, the FDA said.
Find out more about type 2 diabetes at the American Diabetes Association.
Posted: August 2014