Vafseo is an oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor to treat symptomatic anaemia related to chronic kidney disease (CKD) in adults on chronic maintenance dialysis
Vafseo authorisation was backed by data from a comprehensive development programme. (Credit: Robina Weermeijer on Unsplash)
US-based biopharmaceutical company Akebia Therapeutics has secured marketing authorisation from the United Kingdom (UK) Medicines and Healthcare Products Regulatory Agency (MHRA) for Vafseo (vadadustat).
Vafseo is an oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor to treat symptomatic anaemia related to chronic kidney disease (CKD) in adults on chronic maintenance dialysis.
The MHRA authorisation was backed by data from a comprehensive development programme.
The study included more than 7,500 individuals, including the global Phase 3 clinical programme of vadadustat for the treatment of anaemia due to CKD in adult patients on dialysis (INNO2VATE).
Akebia CEO John Butler said: “With the UK MHRA marketing authorisation for Vafseo, we’re pleased to add another approval in Europe.
“Again, I want to recognise our team, and the patients, physicians, investigators, and site coordinators who participated in our global trial and made this approval possible.
“We look forward to completing a partnership in Europe and bringing an additional therapeutic option to patients on dialysis in the United Kingdom.”
In the trial, the primary and key secondary efficacy endpoint in each of the two INNO2VATE studies by the oral inhibitor on adult patients on dialysis.
Vafseo demonstrated non-inferiority to darbepoetin alfa as measured by a mean change in haemoglobin (Hb) between baseline and the primary evaluation period (weeks 24 to 36) and secondary evaluation period (weeks 40 to 52).
According to the results, Vadadustat also achieved the primary safety endpoint of the INNO2VATE programme.
The endpoint is defined as non-inferiority of the oral inhibitor versus darbepoetin alfa in time to the first occurrence of major adverse cardiovascular events, which is the composite of all-cause mortality, non-fatal myocardial infarction, or non-fatal stroke across both INNO2VATE studies.
Vafseo is an investigational new drug and is not approved by the US Food and Drug Administration (FDA). It is cleared in Europe for the same indication as in the UK.
In Japan, the oral inhibitor is authorised to treat anaemia due to CKD in both dialysis-dependent and non-dialysis-dependent adult patients.
In July 2022, Akebia cancelled its collaboration and license deal with Otsuka Pharmaceutical to retain its rights to Vafseo in the US and beyond.