Forxiga dapagliflozin regulatory update

EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) extended its safety review of Type II diabetes drug Invokana canagliflozin from Johnson & Johnson (NYSE:JNJ, New Brunswick, N.J.) to include similar sodium-glucose cotransporter 2 (SGLT2) inhibitors Jardiance empagliflozin from Eli Lilly and Co. (NYSE:LLY, Indianapolis, Ind.) and Boehringer Ingelheim GmbH (Ingelheim, Germany) and Forxiga dapagliflozin from AstraZeneca. In April, the PRAC began reviewing Invokana after an increase in amputations, mostly affecting toes, was observed in the international Phase III CANVAS trial (see BioCentury, April 25). ...