FDA accepts FibroGen's filing seeking clearance of roxadustat for anaemia of chronic kidney disease

FibroGen announced that the FDA accepted a filing seeking approval of roxadustat for the treatment of anaemia of chronic kidney disease (CKD), in both non-dialysis-dependent and dialysis-dependent patients. The regulator has set a target review date for the application of December 20.

"We intend to work closely with the FDA, in collaboration with our partner, AstraZeneca, to make this novel oral therapy available as soon as possible," remarked Peony Yu, FibroGen's chief medical officer. In 2013, AstraZeneca entered into an agreement to develop and commercialise roxadustat, previously known as FG-4592, for the treatment of anaemia associated with CKD and end-stage renal disease.

According to FibroGen, the FDA filing is supported by results from a global Phase III programme that included more than 8000 patients. In November last year, AstraZeneca and FibroGen reported a pooled analyses in which roxadustat demonstrated a cardiovascular safety profile comparable with placebo in patients not on dialysis, and comparable or in some cases better than that of epoetin alpha in patients on dialysis.

The HIF-PH inhibitor is currently approved in China for the treatment of anaemia in CKD patients on dialysis and patients not on dialysis, while it is also authorised in Japan for the treatment of anaemia in CKD patients on dialysis. Meanwhile, FibroGen's partner Astellas plans to file a marketing application with the European Medicines Agency in the first half of 2020.

 

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