FDA rejects FibroGen's anemia drug, demanding an additional clinical trial
Less than a month since an FDA adcomm voted almost unanimously against approving AstraZeneca and FibroGen’s anemia drug roxadustat as a treatment of anemia due to chronic kidney disease, the FDA has sent over a rejection letter and requested an additional clinical study prior to resubmission.
While the rejection is not a complete surprise (shares of FibroGen stock ticked up slightly Wednesday morning, following a nearly 40% plunge after the adcomm), it remains unclear if the two companies will have the appetite to run another clinical trial, given the cardiovascular safety concerns and quality-of-life question marks.
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