Regulatory Focus™ > News Articles > FDA Places Clinical Hold on BMS Drug after Emergence of Unexpected Adverse Events

FDA Places Clinical Hold on BMS Drug after Emergence of Unexpected Adverse Events

Posted 24 August 2012 | By Alexander Gaffney, RAC 

A phase II drug compound under development by Bristol-Myers Squibb for the treatment of hepatitis C has been discontinued after at least one patient death and multiple hospitalizations for adverse events, the company said in a statement.

The compound, BMS-986094, a nucleotide polymerase (NS5B) inhibitor, had been acquired when BMS purchased Inhibitex, a Georgia-based biopharmaceutical company focused on infectious diseases.

In a 23 August statement, BMS said the US Food and Drug Administration (FDA) had placed a clinical hold on the compound after the company alerted it to the death of one patient and the hospitalization of eight others. BMS halted the phase II trial for the drug on 1 August and immediately alerted FDA to the issue, it said.

The company explained that the unexpected adverse events all involved heart and kidney toxicity, but said a causal relationship, "Has not been definitively established."

"The decision to halt development of BMS-986094 has been guided by our overriding interest in protecting patients," said Elliott Sigal, BMS executive vice president and chief scientific officer. "In the interest of all patients participating in hepatitis C clinical studies, and in cooperation with FDA, we will make relevant information on BMS-986094 available to inform the development of other investigational compounds to treat hepatitis C."


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