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.
FibroGen scored the first roxa approval back in 2018 from China, where pharma partner AstraZeneca is taking charge of commercialization.
In Europe, where a thumbs up from regulators has pointed to an approval for weeks, FibroGen is teaming up with Astellas on the launch. On top of handing over $120 million in milestone payments over the OK, the Japanese pharma will also pay royalties to the biotech on future sales.
“Today’s approval provides patients, regardless of dialysis status, with a first-in-class treatment option to address the multifaceted nature of this condition,” said Steven Benner, president of development at Astellas.
The FDA takes a different view. After a shocking acknowledgment about manipulated cardiovascular data that went into its NDA package, FibroGen drew significant criticism and questions from the agency as well as the advisory committee, which voted overwhelmingly against approval.
Concerns ranged from safety, scant evidence of quality-of-life improvements, and under-representation of certain ethnic groups, to skepticism about the company’s planned post-marketing study and dosing changes. A complete response letter followed soon after.