FDA authorizes Lilly’s baricitinib as Covid-19 treatment

 The U.S. Food and Drug Administration has revised its emergency use authorization (EUA) for Lilly’s baricitinib and authorized it as a Covid-19 treatment.

The U.S. FDA has authorized Lilly’s baricitinib as monotherapy for Covid-19.
Baricitinib, developed by Eli Lilly as a treatment for rheumatoid arthritis, is sold under the brand name Olumiant. The FDA granted EUA for the combination of remdesivir and baricitinib as a treatment for Covid-19 in November.

Under the revised authorization, U.S. medical institutions will use the treatment on hospitalized adults and pediatric patients two years of age or older requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).

“This revision to the EUA for baricitinib was supported by data from a clinical trial of hospitalized patients with Covid-19, where baricitinib showed a reduction in the proportion of patients who died through 28 days of follow-up compared to patients treated with the standard of care for COVID-19 alone,” the FDA said. “This study did not require hospitals to administer a combination of baricitinib and remdesivir, and most of the patients did not receive remdesivir.”

The study provided information previously unavailable to the agency at the time of the original authorization, the agency added.

The FDA added that while the revised EUA no longer requires hospitals to use baricitinib in combination with remdesivir, the agency’s letter of authorization notes that the trial supporting this revision did not raise questions about the safety or efficacy of baricitinib when used in combination with remdesivir for the treatment of patients hospitalized due to Covid-19 requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or ECMO.

“Therefore, the use of baricitinib in combination with remdesivir is not contraindicated under the terms and conditions of this authorization,” the FDA said. “A contraindication describes when the use of a product is not appropriate.”

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