GlaxoSmithKline PLC (LSE:GSK) hit a major milestone after a marketing submission for its drug for treating chronic kidney disease was accepted by the European Medicines Agency.
The group submitted its application after the ASCEND Phase III clinical trial programme for daprodustat , which consisted of five trials, all met their co-primary efficacy and safety endpoints.
Over 8,000 patients were treated in the programme for more than four years.
The investigational oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) is designed to treat patients with anaemia of chronic kidney disease.
GSK said the EMA file acceptance was the first major regulatory milestone since the approval of Duvroq in Japan, which uses daprodustat to treat patients with renal anaemia.
Last week, GSK had its first COVID-19 vaccine approved in Canada, while it is also engaged in a demerger of its consumer division Haleon.
GSK was trading up 0.57% at 1,554.4p on opening this morning in response to the news.