EU thumbs up for roxadustat, but US panel approaches

A green light from the EU's CHMP for Fibrogen’s roxadustat takes the anaemia pill a step closer to a second major market. It has been sold in Japan as Evrenzo since 2019 by Astellas, and the Japanese drug maker also has rights in Europe. That Astellas managed to file the correct set of data potentially contributed to a straightforward approval process – in the US Fibrogen oversaw a complete fiasco that involved more flattering data being submitted. A July 15 FDA advisory panel will reveal what the US regulator made of all this, but ultimately the perceived cardiac risk profile of roxadustat is important. Thus the CHMP’s decision is encouraging: while the full label has yet to emerge the proposed indication is anaemia associated with chronic kidney disease. Questions over cardiac safety raised expectations of restricting use to patients on dialysis; expanding into the pre-dialysis market would commercially be a game changer. The broader EU label seems to be on the cards, which is good news for all those involved. Glaxosmithkline’s daprodustat will yield pivotal data later this year, and Akebia has a Pdufa set for next March with its candidate, vadadustat.

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