LONDON (dpa-AFX) - GlaxoSmithKline Plc (GSK) said on Tuesday that its marketing authorisation application for Daprodustat has been accepted for review by the European Medicines Agency.
Daprodustat, an investigational oral hypoxia-inducible factor prolyl hydroxylase inhibitor, is proposed for the treatment of patients with anaemia of chronic kidney disease.
The submission of Daprodustat regulatory filing was based on the results of ASCEND Phase III clinical trial programme, consisting of five trials that all met their co-primary efficacy and safety endpoints.
Daprodustat is currently approved in Japan under the brand name Duvroq for 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', the company noted.
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