Wednesday, October 27, 2021

U.S. FDA allows Lilly’s COVID-19 drug to be taken without remdesivir

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(Reuters) – The U.S. health regulator expanded the emergency use authorization for Eli Lilly’s COVID-19 drug baricitinib, saying it could now be used without taking Gilead’s drug remdesivir along with it, Lilly said on Thursday.

In November, the U.S. Food and Drug Administration (FDA) approved Lilly and Incyte’s arthritis drug, baricitinib, in combination with remdesivir, to treat COVID-19 patients.

“Based on the increasing body of evidence, we are confident in the potential of baricitinib as an important treatment for the hospitalized COVID-19 patient population requiring supplemental oxygen,” Lilly said on Thursday.

FDA’s expanded use for baricitinib was based on results from a trial done by the company in April.

The trial did not meet the main goal of preventing progression to ventilator use in hospitalized COVID-19 patients. However, the study showed baricitinib-treated patients were less likely than those receiving standard of care to progress to ventilator use or death.

The study enrolled 1,525 hospitalized COVID-19 patients who received either baricitinib or a placebo, along with the standard of care, which included corticosteroids and remdesivir.

(Reporting by Dania Nadeem in Bengaluru; Editing by Shounak Dasgupta)

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