Fibrogen was expecting the Food and Drug Administration to complete a review of its experimental anemia pill and render an approval decision by March 20. But in a surprising — and concerning — move announced Monday evening, the FDA has instead decided to convene a meeting of outside experts to review the drug’s clinical data.
The scheduling of the advisory panel this late in the review process is unusual and will delay the approval of the oral drug, called roxadustat, Fibrogen said Monday.
Fibrogen shares fell 21% to $40 in Monday’s after-hours trading session. Investors see an increased risk that the FDA now believes there’s something amiss in the roxadustat clinical data that might derail the approval altogether.
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Drug is working well in Asia Why cant we approve it here. Anemia in CKD is diffcult and responds to Roxedustat