Johnson & Johnson’s Janssen Research & Development is hoping to win approval for its new type 2 diabetes treatment, a fixed-dose therapy combining canagliflozin and immediate release metformin. Canagliflozin is a selective sodium glucose co-transporter 2 (SGLT2) inhibitor that works by blocking the reabsorption of glucose by the kidney, increasing glucose excretion, and lowering blood glucose levels. Metformin, an older medication, is a biguanide that lowers blood glucose levels by decreasing the amount of glucose made by the liver.
In its New Drug Application (NDA) to the Food and Drug Administration (FDA), Janssen provided data from the comprehensive global Phase 3 clinical development program for canaglitflozin, as well as data from a study in patients who have or are at high risk for developing cardiovascular disease, called the CANagliflozin cardioVascular Assessment Study (CANVAS). Researchers evaluated the safety and efficacy of canagliflozin across the spectrum of type 2 diabetes and included placebo- and active comparator-controlled studies.
Drug companies are quick to find safe and effective treatments for type 2 diabetes. The chronic disease has become a worldwide epidemic, and an estimated one in three Americans is expected to become diabetic by 2050. Most diabetics will need to rely on medication to control their blood sugar levels. However, many of these medications can cause serious side effects.
In 2010, the FDA severely restricted the type 2 diabetes drug Avandia after it was tied to fatal cardiovascular events. In 2011, the FDA issued a warning that the type 2 diabetes treatment Actos increased the risk for bladder cancer, especially in patients who used the drug long-term. Both of these medications have brought in billions of dollars of revenues for drug companies over the years, and both drugs are the source of numerous lawsuits by people who say the drug companies did not properly warn them that using the medications could seriously injure or kill them.