2nd Feb 2023 09:26
(Alliance News) - GSK PLC on Thursday said its Jesduvroq drug has been approved by the US Food & Drug Administration for anaemia of chronic kidney disease in adults on dialysis.
GSK is a London-based multinational pharmaceutical and biotechnology company.
The FTSE-100 firm said Jesduvroq, known as daprodustat generically, is the only oral hypoxia-inducible factor prolyl hydroxylase inhibitor approved in the US. It provides adults on dialysis with anaemia of chronic kidney disease a new oral treatment option.
The approval was based on results from the Ascend trial which assessed the efficacy and safety of Jesduvroq.
Chief Scientific Officer Tony Wood said: "Over the last several decades, there has been little innovation in anaemia of CKD. We are proud to have developed Jesduvroq as a new oral treatment where there is a patient desire for more options."
CKD is characterised by a progressive loss of kidney function, which affects 700 million patients worldwide, with an estimated one in seven patients also developing anaemia.
GSK added that a marketing authorisation application for daprodustat is currently under review with the European Medicines Agency, with a decision expected in the first half of 2023.
In December, GSK said the European Medicines Agency had accepted a marketing authorisation application for momelotinib, its treatment for myelofibrosis, which is a rare type of bone marrow cancer.
Shares were up 0.3% at 1,423.90 pence each on Thursday morning in London.
By Xindi Wei, Alliance News reporter
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