⁍ Regeneron Pharmaceuticals said it would stop enrolling patients receiving advanced COVID-19 care in a trial testing its experimental antibody treatment in hospitalized patients.
⁍ The drugmaker said on Wednesday the treatment lowers virus loads in some non-hospitalized patients.
⁍ U.S. President Donald Trump received the treatment early in his illness, before he was hospitalized, and has credited it for his recovery from COVID-19.
– President Trump’s claim that an experimental Ebola treatment helped him recover from the illness appears to have been premature. On Friday, Regeneron Pharmaceuticals said it would stop enrolling patients in a late-stage clinical trial testing the antibody treatment in hospitalized patients, based on the recommendation of an independent safety board, Reuters reports. The company said the recommendation was based on a potential safety signal and an unfavorable risk-benefit profile at this time. Rival Eli Lilly & Co stopped enrolling such patients based on a similar suggestion earlier this week. The drugmaker said on Wednesday the treatment lowers virus loads in some non-hospitalized patients. Trump received the treatment early in his illness, before he was hospitalized, and has credited it for his recovery from COVID-19. Regeneron said it continues to enroll other types of patients for trials. The independent data monitoring committee backed the enrollment in non-hospitalized patients as well as hospitalized 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 authorization in mild-to-moderate patients at high risk for poor outcome. President Trump had said he would push for an EUA for it and make it free to Americans.
Source: https://www.reuters.com/article/health-coronavirus-regeneron-pharms/update-1-regeneron-to-stop-enrolling-very-sick-covid-19-patients-in-antibody-trials-idUSL4N2HL4IZ