Daprodustat is an investigational oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) that is indicated to treat anaemia of CKD in adult patients not on dialysis and on dialysis.
The company’s application was based on positive data obtained from the ASCEND Phase III clinical trial programme.
The programme included five Phase III studies which were designed to evaluate daprodustat’s efficacy and safety to treat anaemia of CKD across the disease pathway.
More than 8,000 subjects who previously received treatment for up to 4.26 years were recruited for the programme.
The company stated that all the five clinical trials met their co-primary efficacy and safety endpoints.
GlaxoSmithKline said in a statement: “These studies demonstrated that daprodustat improved and/or maintained haemoglobin (Hb) within target level (10-11.5 g/dL) without increased major adverse cardiovascular events (MACE) in the intention-to-treat populations in each pivotal study, compared to the standard of care, an erythropoietin stimulating agent (ESA), across both non-dialysis and dialysis patient settings.”
At present, daprodustat is approved in Japan as Duvroq for the treatment of renal anaemia.
Since the approval in Japan in 2020, the EMA submission is marked as the first major regulatory milestone for daprodustat.
The company plans to continue regulatory filings for the therapy with health authorities across the world throughout this year.
Last month, GlaxoSmithKline and Vir Biotechnology signed an agreement to expand their Covid-19 collaboration to advance new therapeutics for influenza and other respiratory viruses.