Janssen gains FDA approval of Invokana for type 2 diabetes; files simeprevir NDA

There were a couple of good news items for Johnson & Johnson (NYSE: JNJ) unit Janssen Pharmaceuticals on Friday (March 29), firstly, with the US Food and Drug Administration approving the firm’s oral drug Invokana (canagliflozin), 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,” said Mary Parks, 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,” she added.

However, the FDA is requiring five post-marketing 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.