Akebia Receives Approval for Vafseo to Treat Anaemia

Akebia Receives Approval for Vafseo to Treat Anaemia

By, Admin 1 April 2024

CSL Vifor’s partner Akebia receives US FDA approval for Vafseo to treat anaemia due to CKD in dialysis-dependent adult patients

Overview

CSL Vifor’s partner Akebia Therapeutics, Inc. announced that the US Food and Drug Administration (FDA) has approved Vafseo (vadadustat) tablets for the treatment of anaemia due to chronic kidney disease (CKD) in adults who have been receiving dialysis for at least three months. Vafseo is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) developed by Akebia.

Words from CSL Vifor

"We congratulate our partner Akebia on the FDA approval, which represents an important moment in our shared efforts toward improving the lives of dialysis patients with anemia due to CKD in the US," said Hervé Gisserot, general manager of CSL Vifor. ""As we continue to deliver on our promise for patients and public health, we are eager to closely collaborate with our partners to make this new oral treatment option available to patients."

Vafseo Is Not Indicated for Use:

"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, M.D., M.P.H., Professor of Medicine, Division of Nephrology at Stanford University and Co-Chair of the independent Executive Steering Committee for PRO2TECT and INNO2VATE, the global phase 3 clinical development programs for Vafseo.

Behind Approval: INNO2VATE Programme

  • The approval of Vafseo for the treatment of anaemia due to CKD in adults who have been receiving dialysis for at least three months is based on efficacy and safety data from the INNO2VATE programme and an assessment of post marketing safety data from Japan where Vafseo was launched in August 2020. 
  • Results from the INNO2VATE programme were published in the New England Journal of Medicine: (N Engl J Med 2021; 384:1601-1612); (N Engl J Med 2021; 384:1589-1600).

Exclusive License

CSL Vifor has been granted an exclusive license to sell Vafseo to Fresenius Kidney Care dialysis centers and specific other third-party dialysis organizations in the US, allowing us to potentially reach approximately 60% of the dialysis patients in the country.

About Anaemia

  • Anaemia is a condition in which a person lacks enough healthy red blood cells to carry adequate oxygen to the body's tissues. 
  • It commonly occurs in people with CKD because their kidneys do not produce enough erythropoietin, a hormone that helps regulate production of red blood cells. 
  • Anaemia due to CKD can have a profound impact on a person's quality of life1 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 morbidity and mortality2 in people with CKD.
  • Epidemiology
  • Approximately 500,000 adult patients in the US on dialysis suffer from anemia due to CKD3, which may be associated with many adverse clinical outcomes. 
  • 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. 
  • Today, most CKD patients are treated for anaemia with injectable erythropoiesis-stimulating agents mostly administered at dialysis centres.

Vafseo Tablets

  • Vafseo tablets is a once-daily oral hypoxia-inducible factor prolyl hydroxylase inhibitor that activates the physiologic response to hypoxia to stimulate endogenous production of erythropoietin, increasing haemoglobin and red blood cell production to manage anaemia. Vafseo is approved for use in 37 countries.
  • Indication
  • Vafseo is indicated for the treatment of anaemia due to chronic kidney disease (CKD) in adults who have been receiving dialysis for at least three months.
  • Vafseo has not been shown to improve quality of life, fatigue, or patient well-being.

Vafseo Is Not Indicated for Use: 

As a substitute for red blood cell transfusions in patients who require immediate correction of anaemia: In patients with anaemia due to CKD not on dialysis.

CSL Vifor

  • CSL Vifor is a global partner of choice for pharmaceuticals and innovative, leading therapies in iron deficiency and nephrology. 
  • The company specialize in strategic global partnering, in-licensing and developing, manufacturing and marketing pharmaceutical products for precision healthcare, aiming to help patients around the world lead better, healthier lives.

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