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(Alliance News) - GlaxoSmithKline PLC on Monday said its drug Duvroq had been given its first approval in Japan to treat anaemia caused by chronic kidney disease.
The Brentford-headquartered pharmaceutical firm said the Japan Ministry of Health, Labour & Welfare approved Duvroq, the brand name for daprodustat, to treat anaemia from chronic kidney disease.
Anaemia is common in chronic kidney disease patients, as the kidneys stop making enough of a hormone called erythropoietin, which is involved in prompting red blood call production.
Japanese approval was mostly based on a phase 3 programme, which was conducted in Japan and evaluated Duvroq in patients across the chronic kidney disease spectrum, including those not on dialysis.
The drug has not been approved anywhere outside of Japan but Glaxo said its ongoing phase 3 global programme, including the Ascend-D and Ascend-ND studies, will support further submissions worldwide.
Duvroq is taken only as a once-daily pill in dialysis and non-dialysis patients, unlike standard care which requires injections. In Japan, Duvroq will be distributed exclusively by Kyowa Kirin Co Ltd under the strategic commercialisation deal between the two companies announced in 2018.
Hal Barron, chief scientific officer & president of R&D at Glaxo, said: "The approval of Duvroq brings a new, convenient oral treatment option to nearly 3.5 million patients in Japan who have anaemia associated with renal disease. We are pleased with this first approval and look forward to sharing data from our ongoing phase III programme as we seek to help many more patients suffering with this disease around the world."
Shares in Glaxo were up 0.2% at 1,651.00 pence in London on Monday morning.
By Anna Farley; annafarley@alliancenews.com
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