Regeneron Pharmaceuticals has paused enrollment of critically ill COVID-19 patients in its trial studying the antibody cocktail treatment that was given to President Trump earlier this month. The decision is due to potential safety concerns.
The drug maker on Friday said it was suspending the enrollment of hospitalized COVID-19 patients requiring high-flow oxygen or mechanical ventilation after an independent monitoring committee observed “a potential safety signal and an unfavorable risk/benefit profile at this time.”
The enrollment of patients in this category will be on hold pending the collection and analysis of additional data.
Trials will continue to test the antibody cocktail in hospitalized patients requiring little or no extra oxygen. Other trials involving mild or moderately ill patients can also move forward.
The drug has shown encouraging results. Regeneron on Wednesday said early data showed the therapy reduced COVID-19 related medical visits by 57 percent.
Regeneron earlier this month asked the Food and Drug Administration for emergency approval and said it would make doses available to the American people at no cost. The drug maker said it could have enough doses for 300,000 people in the coming months.
On Monday, a study of Eli Lilly’s monoclonal antibody in hospitalized patients was stopped after it was found the treatment did not provide any benefit to COVID-19 patients.
Earlier this month, Trump was given a single 8 gram dose of Regeneron’s experimental treatment under a compassionate-use request and credited the drug for helping him overcome the illness.
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