But as experts on the advisory committee pointed out in rejecting FibroGen’s proposal of a different dosing strategy, it’s only a theory without a clinical trial to back it up. Both the FDA and FibroGen have hypothesized that the problem might stem from a fast hemoglobin overshoot seen with roxa. The most concerning safety signal flagged by the FDA centers on roxa’s heart safety profile, including an elevated risk of a composite marker of major adverse cardiovascular events. Given the obvious defeat from roxa’s existing trials, a separate study seems inevitable if FibroGen and AZ still intend to pursue an FDA approval. Analysts had pegged blockbuster expectations to roxa based on the notion that it could offer safety benefits over traditional erythropoietin therapies.īut the agency rejected roxa in both dialysis- and nondialysis-dependent patients after linking it with an increased risk of blood clots, serious infections, seizures and other metabolic and gastrointestinal side effects. Previously, industry watchers thought roxa could become the first drug in the oral HIF-PHI class to reach the U.S. In August, the FDA turned down roxadustat’s application in anemia for kidney disease patients following negative opinions from an external advisory committee and a rough FDA internal review. RELATED: Surprise, surprise: AstraZeneca and FibroGen's once-hyped anemia drug roxadustat hits an FDA wall positions, of which 30% are existing jobs. The California biotech plans to reduce its projected spending by about $100 million a year for the next three years, Conterno said. As the partners navigate that process, FibroGen has started cutting expenses to focus on roxadustat and pancreatic cancer candidate pamrevlumab.