AstraZeneca Exanta Liver Toxicity Outweighs Benefit – FDA Advisory Cmte.
This article was originally published in The Pink Sheet Daily
Executive Summary
Cardiovascular & Renal Drugs Advisory Committee votes against recommending approval for all three indications AstraZeneca is seeking for the anticoagulant. The firm’s proposed risk management plan did not seem adequate to prevent severe liver injury, committee members agree.