Last Updated: May 12, 2022
FDA
approved a new
indication (PDF) for Olumiant (baricitinib) for the treatment of COVID-19 in
hospitalized adults requiring supplemental oxygen, non-invasive or invasive
mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). Olumiant
is the first immunomodulatory treatment for COVID-19 to receive FDA approval.
FDA
first issued an Emergency Use Authorization (EUA) for Olumiant
in combination with remdesivir to treat COVID-19 in hospitalized
adults and pediatric patients on November 19, 2020. On July 28, 2021, the FDA
revised the EUA to authorize Olumiant as a standalone treatment. Olumiant
remains under EUA status for hospitalized pediatric patients 2 to less than 18
years of age requiring supplemental oxygen, non-invasive or invasive mechanical
ventilation, or ECMO.
FDA
has revised the Letter of
Authorization (PDF) and associated fact sheets to remove
the population covered under the approved indication. Common side effects of
Olumiant and the recommended dosage for the approved population are included in
the prescribing
information (PDF).
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. (May 10, 2022)