BioCentury
ARTICLE | Clinical News

Invokana canagliflozin regulatory update

April 25, 2016 7:00 AM UTC

EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) began a review of Type II diabetes drug Invokana canagliflozin after an increase in amputations, mostly affecting toes, was observed in the ongoing international Phase III CANVAS trial. EMA said “a small, non-statistically significant increase” in the number of amputations also occurred in the ongoing international Phase IV CANVAS-R trial of the sodium-glucose cotransporter 2 (SGLT2) inhibitor. Both trials involve patients at high risk of problems with the heart and blood vessels. EMA said no increase in lower limb amputations was seen in 12 other completed trials of Invokana. ...