Ionis, Akcea team face some tough questions on safety as FDA insiders ponder risks linked to volanesorsen
Researchers for Ionis’ $IONS majority-owned spinout Akcea will have plenty of persuading to do this week if they ever expect to get their drug volanesorsen on the market.
The FDA internal review came out today, reflecting the same deep concerns that analysts have expressed about the safety of a drug that has been linked with repeated instances of sudden and dangerous drops in platelet counts. Platelets are needed to trigger the clotting that stops bleeding.
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