US FDA raises efficacy questions about Abbott's Humira in UC
This article was originally published in Scrip
Executive Summary
While the two placebo-controlled trials supporting an expanded indication for Abbott's anti-tumour necrosis factor (TNF) agent Humira (adalimumab) as a treatment for ulcerative colitis (UC) were adequate, several limitations introduced uncertainty into the strength and robustness of the efficacy findings, US FDA drug and statistical reviewers said on 24 August, declaring that additional studies may be needed for the new indication.