US FDA drops 2nd hold bomb on Idenix in wake of BMS nuke death
This article was originally published in Scrip
Executive Summary
The US FDA's concerns about Bristol-Myers Squibb's now discontinued experimental nucleotide polymerase NS5B inhibitor BMS-094 – which has been linked, although not definitively, to heart and kidney toxicities, including one death – has taken a second toll on Idenix Pharmaceuticals' nuke program, with regulators placing a full clinical hold on the firm's next-generation NS5B IDX19368, under what the company is calling a "precautionary" measure.