A new and closely watched anemia drug developed by Fibrogen has been delivered a tough blow by the FDA.
This week, the company announced that it received a complete response letter from the agency for roxadustat, an oral treatment that mimics the body’s behavior in high altitudes and stimulates the production of red blood cells to treat anemia in patients with chronic kidney disease.
Roxadustat has had a shaky road up to this point. In April, Fibrogen shocked investors by admitting that it made post-hoc changes to phase 3 trial data that made the drug appear safer for certain patients than it really was. An FDA advisory committee also voted against the drug last month, citing safety and efficacy worries.
Yet, the company could make up for lost ground in the U.S. with approvals it has won in other countries for roxadustat including China, Japan, Chile and South Korea. It is also under review in the EU.
In its CRL, the FDA asked Fibrogen to conduct another study of the drug if it wants to apply for approval again.
