Akebia gets FDA approval of renal anaemia therapy Vafseo

2024-03-28

上市批准

Akebia Therapeutics gained FDA approval of Vafseo (vadadustat) for the treatment of anaemia due to chronic kidney disease (CKD), but in a narrower patient population than hoped for when it first sought clearance back in 2021.

The original application aimed to gain approval of the once-daily oral HIF-PH inhibitor in both adult patients on dialysis and those not on dialysis. However, the FDA rejected the filing after Vafseo failed to demonstrate non-inferiority with regard to major adverse cardiovascular events (MACE) versus Amgen's Aranesp (darbepoetin alfa) in CKD patients not dependent on dialysis.

While Akebia appealed the decision, the FDA stood firm, but allowed the company to resubmit an application for dialysis dependent patients without the need to conduct further clinical studies. The subsequent filing was made in September last year.

Specifically, the FDA approved Vafseo for the treatment of anaemia due to CKD in adults who have been receiving dialysis for at least three months. The product carries a boxed warning regarding an increased risk of death, myocardial infarction, stroke, venous thromboembolism and thrombosis of vascular access.

More to come.

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