US FDA approves Lilly and Incyte’s Olumiant for treating certain hospitalised patients with COVID-19

Eli Lilly and Company and Incyte announced recently that the US Food and Drug Administration (FDA) has approved Olumiant (baricitinib) for the treatment of COVID-19 in hospitalised adults requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO) with a recommended dose of 4 mg once daily for 14 days or until hospital discharge, whichever comes first, a company statement said.

The FDA’s approval is supported by results from two randomised, double-blind, placebo-controlled phase-III studies (ACTT-2 and COV-BARRIER, including the COV-BARRIER OS 7 addendum study), announced previously. No new safety signals potentially related to the use of Olumiant were identified in the studies, the statement added.

It also informed that Baricitinib has been available in the US under Emergency Use Authorisation (EUA) since November 2020. An EUA will remain in place for hospitalised paediatric patients two to less than 18 years old who require various degrees of oxygen support. The emergency authorisation is not an approval, and is temporary for the duration where circumstances justify the authorisation.

Lilly has submitted applications for regulatory approval or authorisation to multiple regulatory agencies around the world and anticipates further regulatory decisions to follow, the statement noted.

The US FDA-approved labelling for Olumiant carries a boxed warning for risk of serious infections, mortality, malignancy, Major Adverse Cardiovascular Events (MACE) and thrombosis. Patients treated with Olumiant are at an increased risk of serious bacterial, fungal, viral and opportunistic infections leading to hospitalisation or death, including tuberculosis. Higher rates of all-cause mortality and MACE have been observed with another JAK inhibitor versus tumour necrosis factor (TNF) blockers. Malignancies and thrombosis have occurred in patients treated with Olumiant and higher rates of each have been observed with another JAK inhibitor versus TNF blockers, the statement concluded.