A panel of outside experts convened by the Food and Drug Administration concluded Thursday that the risks of blood clots and other safety concerns tied to Fibrogen’s anemia pill were too high to support the drug’s approval for patients with chronic kidney disease.
The FDA is not required to abide by the panel’s recommendations, but the lopsided votes against the Fibrogen drug called roxadustat — backed by strong concerns about its safety in vulnerable patients — makes it all but certain the drug will not reach the market without more data from additional clinical trials.
Fibrogen touted roxadustat as a potential blockbuster medicine, representing a new way to treat anemia in kidney disease patients with a pill, instead of the injections required by current treatments. But problems with the FDA’s review of roxadustat began to appear in March when the agency delayed the approval decision so that it could convene a meeting of outside experts.
About the Author Reprints
Create a display name to comment
This name will appear with your comment
