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

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

Shots:

  • The approval is based on P-III DAPA-CKD trial assessing Farxiga (qd, 10 mg) + SOC vs PBO in 4304 patients with CKD stages 2-4 and elevated urinary albumin excretion, with/out T2D
  • Results: 39% reduction in relative risk of worsening of renal function or risk of CV or renal death, ARR (5.3%) @2.4yrs., and reduction in the risk of death by 31%. The approval follows the US FDA’s PR designation granted in early 2021
  • The exploratory analyses of the P-III DECLARE-TIMI 58 trial evaluating the effect of Farxiga vs PBO in 14000 patients on CV outcomes support the conclusion that Farxiga is effective in patients with less advanced CKD

Click here to­ read full press release/ article | Ref: Businesswire | Image: Twitter

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