AstraZeneca’s Farxiga (dapagliflozin) Receives the US FDA’s Priority Review for Chronic Kidney Disease

 AstraZeneca’s Farxiga (dapagliflozin) Receives the US FDA’s Priority Review for Chronic Kidney Disease

AstraZeneca’s Farxiga (dapagliflozin) Receives the US FDA’s Priority Review for Chronic Kidney Disease

Shots:

  • The acceptance of regulatory submission and the granting of PR is based on P-III DAPA-CKD study assessing Farxiga (10mg, qd) + SOC vs PBO in 4,304 patients with CKD stages 2-4 and elevated urinary albumin excretion, with/ out T2D
  • The study demonstrated that the therapy reduced the risk of the composite of worsening of renal function or risk of CV or renal death by 39% and reduction in the risk of death from any cause by 31%. The safety & tolerability is consistent with the known safety profile of the therapy
  • Farxiga is an SGLT2 inhibitor and has received the US FDA’s BTD for CKD with/ out T2D. The anticipated PDUFA date for the therapy is Q2’21

Click here ­to­ read full press release/ article | Ref: AstraZeneca | Image: Nutralngredients-Asia

Tuba Khan

Tuba Khan is Senior Editor at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in the Life sciences industry. She covers Biopharma, MedTech, and Digital health segments. Tuba also has an experience of digital and social media marketing and runs the campaigns independently. She can be contacted on tuba@pharmashots.com

Related post