Shots:

• The approval is based on the results of CANVAS (CANagliflozin cardioVascular Assessment Study) Program assessing Invokana vs PBO + SoC in 10-000 adults having or at risk CV disease with T2D & recommendations from ADA & AACE for Invokana + SGLT2 inhibitor to reduce CV events
• CANVAS study results: overall reduction in risk of heart attack- stroke and CV death 14%; with CV disease 18%; Reduction in MACE events 18%; MACE risk reduction nonfatal heart attack- nonfatal stroke- CV death (15%- 10%- 13%)
• Invokana PO is a novel medication approved for reduction in MACE events. Janssen has acquired US rights of Invokana from Mitsubishi Tanabe and also received first FDA approval on 29 Mar- 2018 indicated for glycemic control in adults with T2D

Ref: J&J| Image: Janssen