While figuring out post-CRL future for roxadustat, FibroGen celebrates Europe OK with Astellas
The FDA may not be ready to approve FibroGen’s roxadustat before it sees another clinical trial, but the European Commission is swinging its doors wide open.
The oral HIF-PH inhibitor known as roxadustat will now be branded Evrenzo in Europe, to be prescribed for adult patients with symptomatic anemia associated with chronic kidney disease.
By mimicking the effect of high altitude in humans, roxadustat is designed to stimulate the production of red blood cells and therefore increase hemoglobin levels. It’s a different mechanism of action than the traditional injectable erythropoiesis-stimulating agents — which was initially touted as an advantage but also presents a high bar in terms of both adoption and safety.
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