FDA approves Invokana for Type II diabetes

FDA approved an NDA from Johnson & Johnson (NYSE:JNJ) for Invokana canagliflozin to improve glycemic control in adults with Type II diabetes. The pharma plans to launch the product next week. J&J told BioCentury that the wholesale acquisition cost for Invokana is $8.77 per day. The drug is available as 100 and 300 mg once-daily tablets. The pharma is required to conduct five postmarketing trials: a cardiovascular outcomes trial, two pediatric studies, a bone safety study and a pharmacovigilance program to monitor for malignancies, serious cases of pancreatitis, severe hypersensitivity reactions, photosensitivity reactions, liver abnormalities and adverse pregnancy outcomes. In January, an FDA advisory panel voted 10-5 to recommend approval of sodium-glucose cotransporter 2 (SGLT2) inhibitor, the first of its class. The panel voted 8-7 that concerns remain regarding whether J&J had provided sufficient evidence of cardiovascular safety (see BioCentury, Jan. 21) ...