The FDA has granted emergency authorization for Eli Lilly's drug, Olumiant, in combination with Gilead's remdesivir as a treatment for hospitalized COVID-19 patients, Eli Lilly said Nov. 19.
Olumiant is a rheumatoid arthritis drug that combats inflammation. The FDA said the drug was shown to reduce recovery time in COVID-19 patients within 29 days of treatment.
Olumiant, an oral tablet, in combination with remdesivir is approved specifically for hospitalized COVID-19 patients over the age of 2 who require ventilation or supplemental oxygen. It's not approved on its own as a COVID-19 treatment.
"The FDA’s emergency authorization of this combination therapy represents an incremental step forward in the treatment of COVID-19 in hospitalized patients, and FDA’s first authorization of a drug that acts on the inflammation pathway," said Patrizia Cavazzoni, MD, acting director of the FDA’s Center for Drug Evaluation and Research. "Despite advances in the management of COVID-19 infection since the onset of the pandemic, we need more therapies to accelerate recovery, and additional clinical research will be essential to identifying therapies that slow disease progression and lower mortality in the sicker patients."
Eli Lilly said it is working with hospitals, governments and healthcare professionals to boost access to Olumiant.