HQ Team
March 28, 2024: Akebia Therapeutics, a US Massachusetts-based biotechnology company, has got the regulator’s approval for its Vafseo drug to treat anaemia in patients undergoing dialysis for at least three months.
The vadadustat tablets, branded as Vafseo, is a once-daily medicine for people with chronic kidney disease (CKD) to manage anaemia, according to a company statement.
The drug has been approved in 37 countries.
Anaemia is a condition in which a person lacks enough healthy red blood cells to carry adequate oxygen to the body’s tissues.
Erythropoietin
It commonly occurs in people with CKD because their kidneys do not produce enough erythropoietin, a hormone that helps regulate the production of red blood cells.
Anaemia due to CKD can have a profound impact on a person’s quality of life as it can cause fatigue, dizziness, shortness of breath and cognitive dysfunction. Left untreated, anaemia leads to deterioration in health and is associated with increased mortality in people with CKD.
The approval for Vafseo in US markets was based on efficacy and safety data from a final-phase trial and an assessment of post-marketing safety data from Japan, where it began selling in August 2020.
About 500,000 adult patients in the US on dialysis suffer from anaemia due to CKD, which may be associated with many adverse clinical outcomes.
Stimulating agents
The burden of managing uncontrolled anaemia in CKD patients can be substantial, both in terms of healthcare costs and the impact on patients, healthcare providers and caregivers, according to the statement.
Currently, most CKD patients are treated for anaemia with injectable erythropoiesis-stimulating agents mostly administered at dialysis centres.
“Patients receiving maintenance dialysis would benefit from additional therapeutic options that can effectively increase and maintain haemoglobin concentrations within guideline-recommended target ranges,” said Glenn M. Chertow, MD, MPH, Professor of Medicine, Division of Nephrology at Stanford University.
Akebia will execute a launch strategy to drive Vafseo toward the goal of becoming a new oral standard of care for adult dialysis patients, John P. Butler, Chief Executive Officer of Akebia, said.
