The drug maker on Friday said Hospital admission of COVID-19 patients in need of high flow oxygen or mechanical ventilation has been suspended after an independent monitoring committee identified “a potential safety signal and an unfavorable risk-benefit profile at this time”.
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Registration of patients in this category will be suspended until additional data is collected and analyzed.
Studies continue to test the antibody cocktail in hospitalized patients who require little or no additional oxygen. Other studies with mild or moderate patients may also progress.
The drug has shown encouraging results. Regeneron said Wednesday early data showed the therapy reduced COVID-19-related doctor visits by 57 percent.
Regeneron asked the Food and Drug Administration for an emergency permit earlier this month and said it would provide cans to the American people for free. The drug maker said there could be enough doses for 300,000 people in the coming months.
On Monday, a study of Eli Lilly’s monoclonal antibody in hospital patients was halted after it was found the treatment was of no benefit to COVID-19 patients.
Earlier this month, Trump received a single 8-gram dose of Regeneron’s experimental treatment at the Compassionate Request, and credited the drug for helping him overcome the disease.
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