ICER Unsatisfied With Fibrogen’s Roxadustat Evidence; FDA Calls Advisory Committee

ICER held a meeting on February 11^th, during which its independent appraisal committee agreed that it was not possible to determine roxudustat’s effectiveness. The drug is aimed at patients with anemia in the context of chronic kidney disease. Shortly after the meeting, the FDA held a public Advisory Committee to further assess the drug’s safety data. The late timing has brought concern and speculation that FibroGen’s drug may not be sufficiently safe and effective.

“Clinicians are excited about the possibility of a new option for patients with chronic kidney disease, but a panel of clinicians and medical evidence experts expressed frustration with the data on roxadustat during a recent meeting convened by the Institute for Clinical and Economic Review. The California Technology Assessment Forum unanimously agreed that roxadustat lacks sufficient evidence of a net health benefit compared to ESAs or best usual care.” CTAF member Ann Raldow of the University of California remarked, “[I] did find going through all of this data very unsatisfying, given the uncertainty of the data, especially as it relates to all-cause mortality and also [major adverse cardiovascular events].” Read more here.

(Source: Cathy Kelly, Pink Sheet, 3/2/21)