The FDA today approved canagliflozin as an adjunct to diet and exercise for treatment of type 2 diabetes. The drug is the first in its class of SGLT2 inhibitors to receive FDA approval, according to a press release.
Along with approval, the agency is requiring five postmarketing trials: 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; a bone safety study; and two pediatric studies under the Pediatric Research Equity Act, including a pharmacodynamic study and a safety and efficacy study.
Canagliflozin (Invokana, Janssen Pharmaceuticals) has been studied as a standalone therapy and in combination with other type 2 diabetes treatments, including metformin, sulfonyulrea, pioglitazone and insulin. Researchers assessed the drug's safety and efficacy in nine clinical trials involving more than 10,285 patients with type 2 diabetes. Study results showed improvements in HbA1c and fasting plasma glucose after treatment with canagliflozin. The drug, however, should not be used in patients with type 1 diabetes; those with diabetic ketoacidosis; those with severe renal impairment, end-stage renal disease or on dialysis.
The most common side effects of Invokana are vulvovaginal candidiasis and urinary tract infection. Because canagliflozin is associated with a diuretic effect, it can cause a reduction in intravascular volume leading to orthostatic or postural hypotension that may result in symptoms such as dizziness or fainting. This is most common in the first 3 months of therapy.
"Invokana is the first diabetes treatment approved in a new class of drugs known as SGLT2 inhibitors," Mary Parks, MD, director of the Division of Metabolism and Endocrinology Products in the FDA's Center for Drug Evaluation and Research. "We continue to advance innovation with the approval of new drug classes that provide additional treatment options for chronic conditions that impact public health."