FDA approves Janssen’s new diabetes drug

Hannah Blake

pharmaphorum

A first-in-its-class diabetes drug by Johnson &amp, Johnson’s Janssen has been approved by the US Food and Drug Administration.

Invokana (canagliflozin) tablets have been approved as a treatment to be used with diet and exercise, to improve glycemic control in adults with type 2 diabetes.

“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.”

Mary Parks, M.D., director of the Division of Metabolism and Endocrinology Products in the FDA’s Center for Drug Evaluation and Research.

Type 2 diabetes affects approximately 24 million people and accounts for over 90% of diabetes cases in the United States.

Invokana’s 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.

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.