Akebia Therapeutics (NASDAQ:AKBA) shares surged over 25% premarket on Thursday after the U.S. Food and Drug Administration (FDA) approved its Vafseo (vadadustat) tablets for the treatment of anemia due to chronic kidney disease (CKD) in adult patients on dialysis for at least three months.
The drug regulator had previously declined to grant marketing approval for vadadustat on safety concerns.
Approved for use in 37 countries, Vafseo (vadadustat) is a once-daily oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor – a class of oral drugs for the treatment of renal anemia.
The U.S. approval was backed by efficacy and safety data from the global Phase 3 INNO2VATE program and an assessment of post marketing safety data from Japan, where the drug was launched in August 2020.
Akebia (AKBA) plans to commercialize Vafseo in the U.S. alongside partner CSL Vifor (OTCQX:CSLLY), which holds exclusive license to sell Vafseo to Fresenius Kidney Care dialysis centers and other third-party dialysis organizations across the nation.
“In line with the approved label, Akebia will execute a launch strategy to drive Vafseo toward the goal of becoming a new oral standard of care for adult dialysis patients,” the company said in a statement.
GlaxoSmithKline’s (GSK) Jesduvroq (daprodustat) was the first HIF-PH inhibitor to secure FDA approval for the treatment of patients with anemia of CKD on dialysis.