AstraZeneca’s Farxiga (dapagliflozin) Receives the US FDA’s Approval for the Treatment of Heart Failure
Shots:
- The US FDA has approved Farxiga to reduce the risk of CV death, hospitalization for heart failure & urgent HF visits in adults with HF
- The approval was based on the P-III trial (DELIVER) evaluating dapagliflozin (administered as qd in addition to background therapy) vs PBO in 6263 randomized patients with HF with LVEF ≥40% with/out T2D. The results showed an early reduction in the primary composite EPs of CV death or worsening HF in patients with HF with HFmrEF or HFpEF
- The results were published in the NEJM. Farxiga was approved in the US for adults with HFrEF & was also approved for T2D, HFrEF, and CKD in 100+ countries globally incl. the US, the EU, China, and Japan
Ref: AstraZeneca | Image: AstraZeneca
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