FDA approves treatment for COVID-19 in certain hospitalized adults

The US Food and Drug Administration yesterday approved a new indication 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, an arthritis drug marketed by US pharma major Eli Lilly (NYSE: LLY) is the first immunomodulatory treatment for COVID-19 to receive FDA approval. It generated first-quarter 2022 sales of $2555.6 million, up 32% year on year partly due to its emergency use in the covid setting.

The FDA first issued an emergency use authorization (EUA) for  Olumiant in combination with remdesivir – marketed as Veklury by Gilead Sciences (Nasdaq: GILD) - 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 two to less than 18 years of age requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or ECMO. The FDA has revised the  Letter of Authorization 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.

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.