FDA approves new indication for drug to treat severe COVID-19

The FDA on May 11 approved Eli Lilly and partner Incyte’s baricitinib, which goes by the brand name Olumiant, to treat COVID-19 in certain hospitalized adults. 

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The anti-inflammatory drug is approved for hospitalized patients who require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation. The recommended dose is 4 milligrams once daily for 14 days or until hospital discharge, whichever comes first.

“Nearly one million people with COVID-19 have been treated with Olumiant in approximately 15 countries worldwide,” said Patrik Jonsson, senior vice president of Eli Lilly. “Today’s full approval reflects both our confidence in Olumiant’s role in treating these hospitalized patients and Lilly’s tireless efforts to support the medical community and patients in the ongoing fight against COVID-19.”

The drug had been available to treat COVID-19 in eligible patients since November 2020 under an emergency use authorization.  

Olumiant was first approved to treat adults with moderate to severe rheumatoid arthritis. 

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