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The Food and Drug Administration has approved canagliflozin, an oral, once-daily therapy for adult patients with type 2 diabetes.
The drug will be marketed by Janssen Pharmaceuticals as Invokana.
Canagliflozin is the first in a new class of medications known as selective sodium glucose cotransporter 2 (SGLT2) inhibitors; they act by blocking the reabsorption of glucose by the kidney, increasing glucose excretion, and lowering blood glucose levels in people with diabetes who have elevated blood glucose levels, the FDA said in a statement announcing the approval. Canagliflozin was recommended for approval by an FDA advisory panel in a 10-5 vote in January.
For the approval, Janssen submitted the results of nine phase III international studies in almost 10,300 patients, comparing the drug with placebo or active controls, as monotherapy and as add-on therapy to other antihyperglycemic drugs.
The company also submitted the interim results of a cardiovascular outcomes study, required by the FDA for all new type 2 diabetes drugs. In the outcomes study, there were more cardiovascular events in the canagliflozin-treated patients in the first 30 days, but the risk dropped after that to below the threshold set by the FDA as acceptable.
Still, the agency is requiring five postmarketing studies including 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 studies under the Pediatric Research Equity Act, which include a pharmacokinetic and pharmacodynamic study and a safety and efficacy study.
Canagliflozin’s most common side effects are vulvovaginal candidiasis and urinary tract infection. Use of the medication can also lead to orthostatic or postural hypotension; that side effect is most common in the first 3 months of therapy, according to the FDA.
The agency said that the drug should not be used in patients with type 1 diabetes, patients on dialysis, or in patients who have diabetic ketoacidosis, severe renal impairment, or end stage renal disease.
Several other SGLT2 inhibitors are in development, including ipragliflozin and empagliflozin. The FDA declined to approve dapagliflozin in 2012 because of safety concerns.
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