Akebia Therapeutics, Inc. (Nasdaq: AKBA), a US-based, fully integrated biopharmaceutical company, announced on Tuesday that it has received approval from Australia's Therapeutic Goods Administration (TGA) for its Vafseo (vadadustat), an oral hypoxia-inducible factor prolyl hydroxylase inhibitor, intended for the treatment of anaemia related with chronic kidney disease (CKD) in adults on chronic maintenance dialysis.

The TGA approval for Vafseo is based on data from a comprehensive development program that included over 7,500 patients, including the global Phase 3 clinical program of vadadustat for the treatment of anemia due to CKD in adult patients on dialysis (INNO2VATE).

Vadadustat achieved the primary and key secondary efficacy endpoint in each of the two INNO2VATE studies, demonstrating 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). Vadadustat also achieved the primary safety endpoint of the INNO2VATE program, defined as non-inferiority of vadadustat versus darbepoetin alfa in time to 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.