FDA puts partial clinical hold on Gilead's magrolimab + azacitidine studies
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Gilead Sciences (NASDAQ:GILD) announces that the FDA has placed a partial clinical hold on studies evaluating the combination of magrolimab plus azacitidine due to an apparent imbalance in suspected unexpected serious adverse reactions (SUSARs) between study arms.
While no clear trend in the adverse reactions or new safety signal has been identified at this time, the partial clinical hold is being implemented by Gilead across all ongoing magrolimab and azacitidine combination studies worldwide in the best interests of patients as additional data is gathered and analyzed to address the concerns raised by FDA.
During the partial clinical hold, screening and enrollment of new study participants will be paused in any study investigating the combination of magrolimab with azacitidine.
Other magrolimab studies, or cohorts, that are not studying the combination of magrolimab plus azacitidine, will continue without any impact by the partial clinical hold.
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Recently, FDA expanded use of Gilead's COVID drug remdesivir to non-hospitalized patients.