- The FDA has issued a complete response letter regarding the marketing application for FibroGen Inc's FGEN roxadustat for anemia of chronic kidney disease (CKD).
- The letter indicates the FDA will not approve the roxadustat NDA in its present form and has requested an additional clinical study of roxadustat be conducted.
- Roxadustat is approved in China, Japan, Chile, and South Korea for CKD anemia in non-dialysis-dependent (NDD) and dialysis-dependent (DD) adult patients.
- The product received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP). The European Commission decision is expected by the end of August.
- Roxadustat is a HIF-PH inhibitor that promotes erythropoiesis or red blood cell production.
- In July, FDA's Cardiovascular and Renal Drugs Advisory Committee voted 13-to-1 against approval of roxadustat for non-dialysis-dependent patients and 12-to-2 against approval for dialysis-dependent indications.
- Astellas Pharma Inc ALPMF and AstraZeneca plc AZN are collaborating with Fibrogen to develop and commercialize roxadustat.
- Price Action: FGEN shares are down 2.20% at $12.90 premarket on the last check Wednesday.
- Related content: Benzinga's Full FDA Calendar.
© 2024 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
Comments
Loading...
Posted In:
Benzinga simplifies the market for smarter investing
Trade confidently with insights and alerts from analyst ratings, free reports and breaking news that affects the stocks you care about.
Join Now: Free!
Already a member?Sign in