– By Barry Cohen
A drug from San Francisco-based FibroGen Inc. (NASDAQ:FGEN) is one of five medications the Food and Drug Administration is expected to rule on in the next three months in what BioPharma Dive called “the most consequential quarter in the agency’s history.”
FibroGen’s roxadustat could become the first drug in pill form to treat anemia, a condition in which the blood doesn’t have enough healthy red cells. Up till now, people with anemia and damaged kidneys have received injectable biologic drugs like Amgen Inc.’s (NASDAQ:AMGN) Epogen and Aranesp. Roxadustat is the closest to approval among similar pills that are meant to trick the body into thinking it’s in low-oxygen. The drug is a collaborative effort between FibroGen and AstraZeneca (NASDAQ:AZN).
Roxadustat has been shown to work like biologics in patients with chronic kidney disease either on or off of dialysis; it has already been approved in China