European Commission Approves Akebia's Vafseo to Treat Symptomatic Anaemia

According to an announcement by Akebia Therapeutics Inc., the European Commission has approved the marketing of Vafseo™, also known as Vadadustat, which is regarded as an oral inhibitor of the Hypoxia-Inducible Factor Prolyl Hydroxylase (HIF-PH).

A fully integrated biopharmaceutical company called Akebia focuses on treating kidney disease complications. It has a late-stage oral Hypoxia-Inducible Factor Prolyl Hydroxylase Inhibitor (HIF-PHI), Vadadustat, as well as a commercially available medication. Vadustat primarily treats adults on long-term maintenance dialysis for symptomatic anaemia linked to Chronic Kidney Disease (CKD). Anemia associated with CKD is common in dialysis patients and is a crippling condition that may be linked to a variety of unfavorable clinical outcomes. As per the research, patients with CKD may also have insufficient levels of the hormone erythropoietin, which is required to stimulate the production of red blood cells. Vafseo's main ingredient, Vadadustat, affects an enzyme known as HIF-PH. This activates the body's natural defense mechanism, which typically produces erythropoietin and red blood cells in response to low oxygen levels.

According to a recent study of adult dialysis patients, Vadadustat met both the primary and secondary efficacy terminuses in each of the two international phases 3 clinical trials, i.e., INNO2VATE studies (two demonstrating non-inferiority to darbepoetin alfa based on the mean Hemoglobin change between baseline, primary evaluation period (weeks of 24 to 36) and secondary evaluation period (weeks of 40 to 52). Additionally, Vadadustat met the INNO2VATE program's primary safety endpoint, which was the non-inferiority of Vadadustat versus darbepoetin alfa in the interval before the onset of major adverse cardiovascular events, which represents the combined total of deaths from all causes, nonfatal MI, and nonfatal stroke in the two INNO2VATE studies.

The approval of Vafseo by the EC marks an important milestone for Akebia Therapeutics Inc., but it also has significant implications for the hundreds of thousands of Europeans who have been diagnosed with anaemia associated with CKD and are receiving dialysis, according to John P. Butler, Akebia's chief executive officer. He also stated that chronic maintenance dialysis patients would benefit from additional therapeutic options. Also, they were eager to choose a partner in Europe who could quickly get Vafseo to those patients once their request was approved.

This approval comes from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended that the EC approve Vafseo during the middle of the first quarter of 2023. The 27 member states of the European Union, including Iceland, Liechtenstein, and Norway, were all covered by the approval of Vadadustat. Thirty-two nations have now approved Vadadustat.