FDA approves Invokana (Janssen) to treat Type 2 Diabetes

The FDA has on 29 March 2013 approved Invokana (canagliflozin) tablets from Janssen Pharmaceuticals, used with diet and exercise, to improve glycemic control in adults with Type 2 Diabetes. Its safety and effectiveness were evaluated in nine clinical trials involving over 10,285 patients with Type 2 Diabetes. The trials showed improvement in hemoglobin A1c levels (a measure of blood sugar control) and fasting plasma glucose (blood sugar) levels.

Invokana is the first in a new class of medications called sodium glucose co-transporter 2 (SGLT2) inhibitors to be approved in the United States. It is also the only oral, once-daily medication available in the United States offering improved glycemic control while also showing reduced body weight and systolic blood pressure in clinical trials.

The FDA is requiring five postmarketing studies for Invokana: 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 (PREA), including a pharmacokinetic and pharmacodynamic study and a safety and efficacy study.