GSK's kidney disease anaemia drug approved in Japan, taking on Astellas' rival

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GlaxoSmithKline’s drug for anaemia caused by chronic kidney disease daprodustat has been approved in Japan, taking on a recently approved rival from Astellas. 

Marketed under the brand name Duvroq, daprodustat was co-developed with Kyowa Kirin and is taken in tablet form. 

Approval by the Japanese Ministry of Health, Labour and Welfare is the first time any regulator has cleared Duvroq. 

It will compete against Astellas’ roxadustat, the first in the hypoxia-inducible factor prolyl hydroxylase class (HIF-PH) to be approved in Japan in September last year. 

Approval for Duvroq in Japan was primarily based on positive data from a phase 3 programme conducted in Japan.  

The studies evaluated Duvroq for the treatment of anaemia in patients across the spectrum of CKD from stages 3-5.  

This included patients on dialysis, including both hemo- and peritoneal dialysis, and those not on dialysis, regardless of prior anaemia treatment with erythropoiesis-stimulating agents (ESAs).  

In contrast to current standard of care in patients with CKD which requires injections, GSK noted that Duvroq offers convenience with oral administration and flexibility with once-daily dosing for dialysis and non-dialysis patients. 

Duvroq is not approved anywhere else in the world and an ongoing phase 3 programme, including the two cardiovascular outcome studies ASCEND-D and ASCEND-ND, will support regulatory filings in other countries. 

AstraZeneca has US rights for roxadustat and is gearing up for a filing with the FDA after supportive data from a cardiovascular outcomes study published last autumn. 

AZ has been working on roxadustat since 2013, when it signed a deal with FibroGen to develop and market the drug in anaemia associated with chronic kidney disease and end stage renal disease. 

AstraZeneca and FibroGen are collaborating on the development and marketing of roxadustat for the potential treatment of anaemia in the US, China and other markets in the Americas and in Australia/New Zealand, as well as Southeast Asia, with Astellas and Fibrogen holding rights elsewhere.