GlaxoSmithKline PLC said on Tuesday it had received acceptance from Europe’s regulatory body for its application to market daprodustat.
Brentford, England-based GSK said the European Medicines Agency had validated its marketing authorisation application for daprodustat. The application included positive data from its ‘Ascend’ phase III clinical trial programme, the results of which were published in November.
Daprodustat is an investigational oral hypoxia-inducible factor prolyl hydroxylase inhibitor, used to treat chronic anaemia in patients with chronic kidney disease.
It is currently approved as Duvroq in Japan, for use in patients with renal anaemia.
‘The submission to the EMA is the first major regulatory milestone since the approval of Duvroq in Japan in 2020. Regulatory filings are anticipated to continue throughout 2022 with health authorities worldwide,’ GSK said.
GSK’s share price was down 0.1% to 1,543.60 pence each in London on Tuesday morning.
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