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The drug is the first immunomodulatory COVID-19 treatment approved by FDA.
FDA announced on May 10, 2022 that it has approved a new indication for Olumiant (baricitinib) for treating adults hospitalized with COVID-19 who require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). Emergency Use Authorization (EUA) was first issued in November 2020 for Olumiant (baricitinib) in combination with remdesivir. The EUA was revised by FDA in July 2021 to authorize Olumiant as a standalone treatment. The drug still has EUA status for hospitalized pediatric patients 2–18 years of age that require supplemental oxygen, non-invasive or invasive mechanical ventilation, or ECMO. The Letter of Authorization and associated fact sheets have been revised to remove the population covered under the approved indication.
“The FDA continues to work with developers, researchers, manufacturers, and partners to help expedite the development and availability of therapeutic drugs and biological products to prevent or treat COVID-19 through its Coronavirus Treatment Acceleration Program,” the agency stated on its website.