Akebia Therapeutics, Inc. (Nasdaq: AKBA) has just made a remarkable announcement: Vafseo® (vadadustat), an oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor, has been granted marketing authorization in Switzerland for the treatment of symptomatic anemia associated with chronic kidney disease (CKD) in adults on chronic maintenance dialysis. This is an incredible breakthrough for the healthcare industry, and will undoubtedly have a significant impact on the lives of those suffering from CKD.
We are thrilled that our drug, Vafseo, has achieved Swissmedic marketing authorization, bringing the total approvals to 34 countries! Through its European partner Medice, we anticipate Vafseo will be launched soon, providing another therapeutic option for patients undergoing dialysis treatments. Our team at Akebia is dedicated to supporting the launch and making Vafseo accessible to those in need.
It’s estimated that over 325,000 people in Europe alone dealing with CKD, and currently on dialysis, are dealing with anemia associated with this condition. Unfortunately, this anemia is linked to a slew of detrimental clinical outcomes. Let’s take this moment to shed light on this very real issue impacting countless lives.
Swissmedic has approved Vafseo, a breakthrough treatment option for anemia caused by chronic kidney disease in adult dialysis patients, after a thorough evaluation of its development program, including over 7,500 patient studies. This global Phase 3 clinical program, known as INNO2VATE, has brought hope to those affected by anemia and provides them with an effective alternative to existing treatments.
In two influential studies known as INNO2VATE, adult patients on dialysis found success with the use of vadadustat. Compared to darbepoetin alfa, vadadustat demonstrated non-inferiority in both primary and key secondary efficacy endpoints during both the primary evaluation period (weeks 24 to 36) and secondary evaluation period (weeks 40 to 52), as evidenced by the mean change in hemoglobin (Hb).
Moreover, vadadustat also proved to be superior from a safety standpoint, showing non-inferiority to darbepoetin alfa in regards to time to first occurrence of major adverse cardiovascular events. In short, the INNO2VATE studies were a revolutionary success in showing the efficacy of vadadustat for adult patients on dialysis.
Vadadustat is a revolutionary drug that seeks to give the body the same benefits as altitude—without having to leave your couch. This oral hypoxia-inducible factor prolyl hydroxylase inhibitor works by mimicking altitude’s naturally-occurring effect on oxygen availability. By stabilizing the body’s hypoxia-inducible factor, Vadadustat encourages increased red blood cell production, maximizing oxygen delivery to all tissues. Unfortunately, this clever concept is not yet approved by the FDA.
About Akebia Therapeutics
Akebia Therapeutics, Inc. is a biopharmaceutical company on a mission to make a positive difference in the lives of those suffering from kidney disease. Founded in 2007 and based in Cambridge, Massachusetts, the Company is devoted to improving the health of individuals and communities by developing transformative and innovative treatments. Akebia is committed to providing effective treatments so that people with kidney disease can live fuller, healthier lives.
Forward Looking Statement
Akebia Therapeutics, Inc. is set to launch their drug vadadustat in Europe, opening up a world of potential as its success could impact a variety of stakeholders. Even though this drug could provide a number of therapeutic benefits, there are still risks that must be taken into consideration such as regulatory filing decisions by health authorities, the competitive landscape, and more. While Akebia’s success is uncertain, they remain confident in their strategy, plans, and goals for delivering vadadustat to European countries.