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news.The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has provided a positive opinion recommending authorisation of GlaxoSmithKline’s (GSK) daprodustat for symptomatic anaemia linked to chronic kidney disease (CKD).
The EMA CHMP issued a positive opinion for daprodustat based on the findings from three international Phase III clinical trials. Credit: Robina Weermeijer on Unsplash.
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An oral inhibitor of hypoxia-inducible factor prolyl hydroxylase, daprodustat is intended for usage in adult patients who are on chronic maintenance dialysis.
The company is developing the therapy as an oral treatment option for CKD patients with anaemia.
Based on findings from three international Phase III clinical trials in patients from the ASCEND trial programme, the agency issued a positive opinion for the therapy.
The trials analysed the safety and efficacy of daprodustat to treat anaemia of CKD in more than 8,000 patients who received the treatment for up to 4.26 years.
Jesduvroq (daprodustat) tablets received approval from the US Food and Drug Administration (FDA) in February this year to treat CKD-caused anaemia in adults on dialysis for a minimum of four months.
The Japanese Ministry of Health, Labour and Welfare approved the Duvroq (daprodustat) tablets in June 2020, for treatment of patients with anaemia of CKD irrespective of their dialysis status.
CKD is characterised by gradual kidney function loss. Anaemia is a common complication of the ailment and is linked to greater morbidity, mortality and poor quality of life.
