Akebia Therapeutics (NASDAQ: AKBA) stock tumbled over 5% in the early trading hours on Monday.
Akebia Therapeutics (AKBA) announced last week that the U.S. Food and Drug Administration (FDA) has given the green light to Vafseo ® (vadadustat) Tablets for treating anemia caused by chronic kidney disease (CKD) in adult patients undergoing dialysis for a minimum of three months.
Vafseo, a once-daily oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor, demonstrates the ability to activate the physiologic response to hypoxia, thereby stimulating the endogenous production of erythropoietin to manage anemia.
The approval of Vafseo® in the U.S. follows successful regulatory clearance in 37 other countries.
The FDA based its approval of Vafseo on efficacy and safety data from the INNO2VATE program. The FDA evaluated post-marketing safety data from Japan, the launchpad for VAFSEO, in August 2020. The New England Journal of Medicine published the results from the INNO2VATE program.
Akebia has plans to bring Vafseo to the U.S. market with its established commercial team. The company will execute a comprehensive launch strategy to establish Vafseo as the standard oral care for adult dialysis patients.
The launch of Vafseo, slated for the latter half of this year, is projected to hit peak sales of $954 million by 2031, according to an analyst at H.C. Wainwright, as reported by Reuters.
Akebia Therapeutics (NASDAQ: AKBA) Stock Reaction
AKBA stock plunged 5.53% to $1.72 in the early trading hours on Monday. The traders had exchanged hands with 5,359,315 (5.35 million) shares compared to the average daily trading volume of 4.16 million.
