Akebia Therapeutics has received marketing authorisation from the European Commission (EC) for its Vafseo (vadadustat) to treat symptomatic anaemia associated with chronic kidney disease (CKD) in adult patients on chronic maintenance dialysis.
It is applicable to all 27 European Union member states along with Liechtenstein, Norway and Iceland.
Vadadustat is an oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor that has been designed to imitate the physiologic effect of altitude on oxygen availability.
It is currently approved in 32 countries.
Akebia Therapeutics CEO John Butler stated: “We’re extremely pleased the EC has approved Vafseo, an important milestone for Akebia but even more impactful for the hundreds of thousands of Europeans diagnosed with anaemia associated with CKD on dialysis.
“We believe patients receiving chronic maintenance dialysis would benefit from additional therapeutic options.
“With approval, we’re eager to select a European partner who can quickly bring Vafseo to those patients.”
The EC approval is based on the data obtained from a comprehensive development programme, including the global Phase III INNO2VATE clinical programme of vadadustat to treat anaemia due to CKD in adults who are on dialysis.
The findings showed that vadadustat achieved the primary as well as the important secondary efficacy endpoint in two INNO2VATE trials.
Vadadustat also achieved the INNO2VATE programme’s primary safety endpoint. This was defined as its non-inferiority, compared with darbepoetin alfa, in time elapsed before a first major adverse cardiovascular event.
It received approval in Japan to treat anaemia due to CKD in dialysis-dependent and non-dialysis-dependent adult patients.
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