FDA slaps a hold on Agios’ PK drug, forcing the biotech to kill it in favor of an internal rival
A few days ago, Agios $AGIO was trying to decide whether it should take AG-348 or AG-519 into a pivotal trial for rare cases of pyruvate kinase (PK) deficiency. But now the FDA has made the decision for Agios, handing down a clinical hold on AG-519 that persuaded the biotech to scrap the program altogether.
The hold, Agios CEO David Schenkein tells me, was triggered by an earlier case of cholestatic hepatitis that was reported at ASH a little more than a week ago. One of the patients in a bioavailability study taking a 300 mg dose was hit by the liver disease. And even though “she’s improving” while Agios was also “likely to move to 50 mg or lower (for the pivotal), one can’t be sure we wouldn’t have seen this again.”
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