07:16 AM EDT, 03/28/2024 (MT Newswires) -- Akebia Therapeutics ( AKBA ) said late Wednesday the US Food and Drug Administration has approved its Vafseo tablets for the treatment of anemia due to chronic kidney disease in adults on dialysis for at least three months.

Vafseo or vadadustat, a once-daily oral treatment to manage anemia, is now approved in 37 countries, the company said.

The latest approval was based on efficacy and safety data from a study in Japan, where Vafseo was launched in 2020, which was published in the New England Journal of Medicine. Approximately 500,000 adults on dialysis in the US suffer from anemia due to chronic kidney disease, the company said.

Shares of the biopharmaceutical company were up more than 13% in recent Thursday premarket activity.

Price: 2.54, Change: +0.3, Percent Change: +13.39