Olysio Pre-treatment Screening Cleared Way For FDA Nod In Partial And Null Responders
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
FDA reviewers were willing to extend simeprevir’s use to HCV patients who had failed prior pegylated interferon/ribavirin therapy but only if labeling contained a strong recommendation for pre-treatment screening to detect the Q80K polymorphism, which was associated with reduced efficacy.
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