Agios Pharmaceuticals Inc. said Thursday it has halted development of an experimental drug to treat a form of anemia after regulators, concerned about a safety issue surfacing in an early-stage clinical study, put a hold on clinical testing of the compound.
Agios disclosed for the first time Thursday that the Food and Drug Administration had ordered it to suspend testing of the drug after a healthy volunteer in a British clinical trial was diagnosed with drug-induced cholestatic hepatitis, the obstruction of bile secretion. Agios said the patient is being monitored and no other adverse events have been reported. Nonetheless, the company has stopped the British study and a separate palability study with US volunteers.
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