WorldFILE PHOTO: The Regeneron Pharmaceuticals company logo is seen on a building at the company's Westchester campus in Tarrytown, New York, U.S. September 17, 2020. REUTERS/Brendan McDermid30 Oct 2020 11:41PMShare this contentBookmarkNEW YORK: Regeneron Pharmaceuticals said on Friday (Oct 30) it would stop enrolling patients receiving advanced COVID-19 care in a trial testing its experimental antibody treatment in hospitalised patients, based on the recommendation of an independent safety board.
The recommendation was based on a potential safety signal and an unfavourable risk-benefit profile at this time, the company said. Rival Eli Lilly & Co stopped enrolling such patients based on a similar suggestion earlier this week.AdvertisementAdvertisement
The drugmaker said on Wednesday the treatment lowers virus loads in some non-hospitalised patients. US President Donald Trump received the treatment early in his illness, before he was hospitalised, and has credited it for his recovery from COVID-19.READ: Eli Lilly COVID-19 antibody trial paused due to potential safety concern
Regeneron said it continues to enroll other types of patients for trials. The independent data monitoring committee backed the enrollment in non-hospitalised patients as well as hospitalised patients requiring either no or a low level of oxygen.The drugmaker said it would inform the US Food and Drug Administration, which is evaluating the treatment for a potential emergency use authorisation (EUA) in mild-to-moderate patients at high risk for poor outcome.
AdvertisementAdvertisementPresident Trump had said he would push for an EUA for it and make it free to Americans.READ: Regeneron antibodies in demand after Trump COVID-19 treatment, doctors seek more dataRegeneron said it remains blinded to the data - meaning it does not know which patients have received the drug and which have not - and is implementing the recommendations.
The antibody cocktail is being studied in four ongoing late-stage clinical trials, including two studies in hospitalised and non-hospitalised COVID-19 patient. Read more: CNA »
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