Shots:

• The FDA’s Fast Track designation is based on two P-III studies- DAPA-HF and DELIVER assessing Farxiga in patients with heart failure with reduced ejection fraction (HFrEF) and preserved ejection fraction (HFpEF) respectively
• The FT designation is granted due to its ability to reduce the risk of CV deaths or worsening of HF in patients with HFrEF & HFpEF. The FT designation expedite the development and review of new therapies for the treatment of serious conditions with unmet medical needs
• Farxiga (PO- qd) is SGLT2 inhibitor indicated as both monothx. and combination therapy to improve glycemic control with a reduction in weight loss and blood pressure as an adjunct to diet and exercise in adults with T2D. In Aug’2019- Farxiga has received FDA’s FT designation for preventing CV and renal death in CKD patients

Click here to­ read full press release/ article

Ref: AstraZeneca | Image: AstraZeneca