U.S. FDA approves Akebia's anemia drug (updated)

Akebia Therapeutics

28/03/2024 01:17

(Adds details from paragraph 2 onwards)
       March 27 (Reuters) - The U.S. Food and Drug
Administration approved Akebia Therapeutics'  AKBA.O  drug,
vadadustat, to treat anemia caused by chronic kidney disease
(CKD) in dialysis patients, the drugmaker said on Wednesday.
    The drug will be available under the brand name Vafseo, it
added. 
    The FDA had earlier declined to approve vadadustat - a
Hypoxia-inducible factor–prolyl hydroxylase (HIF-PH) inhibitor -
on safety concerns, as it posed an increased risk of blood clot
formations and drug-induced injuries to the liver. 
    The regulator indicated in its letter that Akebia could
explore conducting new studies to potentially show a favorable
benefit-risk assessment of the drug.
    Other HIF-PH inhibitor approved by the health regulator
include GlaxoSmithKline's daprodustat, which helped improve
haemoglobin levels in late-stage trials, according to data
released in July 2021.
    HIF-PH inhibitors are a class of oral drugs designed to
boost production of red blood cells by mimicking the body's
response at high altitudes.
    Akebia's vadadustat is currently approved in 37 countries.
It is approved in Europe, Australia and Taiwan for the treatment
of symptomatic anemia due to CKD in adult patients on chronic
maintenance dialysis. 
    In Japan, vadadustat is approved as a treatment for anemia
due to CKD in both dialysis-dependent and non-dialysis dependent
adult patients.
    H.C. Wainwright analyst Ed Arce estimates the drug's launch
in second half of this year, with peak sales of $954 million in
2031. 
    Anemia, or the low count of red blood cells, is a common
complication of CKD, a condition in which a person's kidneys
cannot filter blood efficiently, causing waste and fluid to
build up in the body.
    According to Centers for Disease Prevention and Control,
about 35.5 million adults in the United States are estimated to
have CKD.


 (Reporting by Pratik Jain, Vaibhav Sadhamta and Mrinmay Dey in
Bengaluru; Editing by Subhranshu Sahu and Rashmi Aich)
 ((Pratik.Jain@thomsonreuters.com;))