FibroGen’s action date for Roxadustat postponed

 

• FibroGen (NASDAQ:FGEN) announced that the FDA has extended the review period of its NDA for Roxadustat by three months, with an updated action date set for March 20.
• In February, the company announced that the FDA accepted the NDA for Roxadustat in the treatment for anemia of chronic kidney disease. The PDUFA date was scheduled for December 20.
• The review is in the final stages and has required an extension of the action date as the company submits additional analyses of existing clinical data for Roxadustat, FibroGen said in the announcement.
• The first in a new class of medicines called HIF-PH inhibitors that promotes erythropoiesis, Roxadustat has already been approved in China, Japan, and Chile for anemia of CKD in adults, and the marketing application for the therapy is also under review in Europe.
• For the development and commercialization of Roxadustat as a potential treatment for anemia, AstraZeneca (NASDAQ:AZN) has partnered with FibroGen for the regions including U.S., China, other markets in the Americas, while Astellas Pharma (OTCPK:ALPMF) is collaborating for Europe and Japan.
• Ahead of the announcement, FibroGen fell sharply in post-market trading on Friday.
• https://seekingalpha.com/news/3646024-fibrogen-s-action-date-for-roxadustat-postponed