Regeneron will halt testing its COVID-19 antibody drug in the sickest hospitalized patients after an independent board found a safety concern, the drugmaker said Oct. 30.
The drugmaker said an independent data monitoring committee observed a “potential safety signal and unfavorable risk/benefit profile.” It didn’t release any other information about the concern.
Regeneron will pause enrollment of hospitalized COVID-19 patients receiving oxygen or ventilation in the trial.
Regeneron’s partial trial halt is the second setback that occured in a weeklong period related to antibody drugs. Eli Lilly said Oct. 26 that a trial testing its COVID-19 antibody drug in hospitalized COVID-19 patients was ended by the National Institute of Allergy and Infectious Diseases after finding it does not improve recovery times or survival rates. The trial had been paused Oct. 13 after an independent committee found a safety concern. Eli Lilly also didn’t release specific details about the safety concern.
Regeneron said the partial halt doesn’t affect other trials testing the antibody drug, including one that is testing it in hospitalized COVID-19 patients receiving low amounts of oxygen, as the drugmaker said the risk-benefit for them remains acceptable. In trials testing the antibody drug in less severe patients, it was shown to reduce virus levels and physician visits.
Regeneron submitted a request Oct. 7 with the FDA for an emergency use authorization of the drug.
Read Regeneron’s full news release here.
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