J&J's diabetes drug is now approved by the U.S. Food and Drug Administration, the agency announced Friday.
The drug, Invokana, helps control diabetes by blocking the re-absorption of urine by the kidney, thus increasing glucose excretion.
In the U.S., the number of people being diagnosed with diabetes has tripled, from 5.6 million in 1980 to 26.9 million in 2010. According to the CDC, by 2050, one in three adults in the U.S. will have diabetes. The condition is the leading cause of blindness, kidney failure and limb amputations not caused by an accident.
"Invokana is the first diabetes treatment approved in a new class of drugs known as sodium-glucose co-transporter 2 (SGLT2) inhibitors. We continue to advance innovation with the approval of new drug classes that provide additional treatment options for chronic conditions that impact public health," said Mary Parks, M.D., director of the Division of Metabolism and Endocrinology Products in the FDA's Center for Drug Evaluation and Research, in a statement.
The new drug's efficacy and safety were tested in more than nine clinical trials on more than 10,000 patients with diabetes type-2. The drug use was associated with good blood sugar control (hemoglobin A1c levels) and lower plasma glucose levels.
The drug shouldn't be used to treat people with diabetes type-1, people with end-stage renal disease or those with increased ketones in their blood.
Side-effects of the drug include vaginal yeast infection, urinary tract infection, headache, dizziness and a drop in blood pressure when standing up, the agency said.
FDA will also be monitoring the drug closely and seeks five post-marketing studies which include a cardiovascular outcome trial, effects of the drug on pancreas and liver and also its effects on pregnancy.
J&J said that Invokana will have a wholesale price of $8.77 per tablet, reports The New York Times. Invokana belongs to a class of drugs called SGLT2 inhibitors. In 2012, the FDA had rejected dapagliflozin from Bristol-Myers Squibb and AstraZeneca, which belongs to the same class of drugs, due to increased risk of breast or bladder cancer.