Concerns over patient safety have
prompted New York-based Bristol-Myers Squibb Co. to discontinue a mid-stage
study of its hepatitis C treatment BMS-986094.
Nine patients in the trial were
hospitalized, including one who died of heart failure. Two patients remain
under hospital care, the drug maker said. “The decision to halt development of
BMS-986094 has been guided by our overriding interest in protecting patients,”
said Elliot Sigal, its chief scientific officer.
Though BMS said it has not yet
determined exactly what caused the patients to become ill, heart and kidney
toxicity are likely a key factor. BMS pledged it would continue to look into
the matter. Meanwhile, the Food and Drug Administration has placed BMS-986094
on a clinical hold, and FDA and the drug maker are monitoring the study
patients.
BMS-986094 was one of two key
experimental hepatitis C treatments in BMS’ portfolio. The other, the compound
daclatasvir, has begun late-stage testing. BMS acquired BMS-986094 along with
other potential treatments as part of its acquisition of drug developer
Inhibitex Inc. earlier this year.
FDA has focused more on experimental
drugs’ cardiovascular risks since Merck & Co.’s agency-approved painkiller
Vioxx was found to double the risk of heart attack or stroke.
The Friends of AIDS Foundation is
dedicated to enhancing the quality of life for HIV positive individuals and
empowering people to make healthy choices to prevent the spread of the HIV
virus. To learn more about The Friends of AIDS Foundation, please visit: http://www.friendsofaids.org.
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