Lilly snags first FDA approval for COVID JAK inhibitor

May 12, 2022

The FDA has approved Eli Lilly’s Olumiant as a treatment for certain patients hospitalized with COVID-19 after authorizing its emergency use last year.

The drug is the only JAK inhibitor currently approved for use against SARS-CoV-2. JAK inhibitors work by regulating overactive Janus kinase signaling pathways, which play a crucial role in immune responses. Abnormal signaling of this kinase has been implicated with many autoimmune disorders.

Olumiant was originally approved for use in patients with rheumatoid arthritis and became one of the first treatments to get emergency authorization to treat COVID-19 in 2020 in combination with Gilead's Veklury (remdesivir). Last July, the FDA broadened Olumiant's EUA to also allow use as a standalone treatment for hospitalized patients who needed oxygen.

Its recent approval now also includes adults requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation. Pediatric patients are currently only covered under last year’s EUA expansion.

The recent approval is supported by results from two previously reported phase 3 studies, ACTT02 and COV-BARRIER. Eli Lilly has applied for approval and authorization from pertinent international regulatory agencies and is awaiting decisions.