Regeneron to stop enrolling very sick COVID-19 patients in antibody trials
(Reuters) – Regeneron Pharmaceuticals said on Friday it would stop enrolling patients receiving advanced COVID-19 care in a trial testing its experimental antibody treatment in hospitalized patients, based on the recommendation of an independent safety board.
The recommendation was based on a potential safety signal and an unfavorable 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.
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.
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 U.S. Food and Drug Administration, which is evaluating the treatment for a potential emergency use authorization (EUA) 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.