FDA Grants Full Approval to Lilly's Oral JAK Inhibitor Olumiant for Hospitalized COVID-19 Patients

Compiled by Fan Dongdong

Recently, the U.S. Food and Drug Administration (FDA) has approved Olumiant (Chinese trade name: Ai Le Ming, generic name: baricitinib), co-developed by Eli Lilly and Company and Incyte Corporation, for use in hospitalized COVID-19 patients. This treatment requires only once-daily oral administration. Olumiant is the first Janus kinase (JAK) inhibitor approved by the U.S. FDA for treating hospitalized COVID-19 patients who require supplemental oxygen, extracorporeal membrane oxygenation (ECMO), or ventilator support.

As early as March this year, according to the latest results from the RECOVERY trial, in hospitalized severe COVID-19 patients, Eli Lilly and Incyte's oral JAK inhibitor Olumiant, combined with other drugs, reduced the risk of death by 13%. (For more details, please click)《Risk of Death Reduced by 13%, Eli Lilly's Oral JAK Inhibitor Olumiant Effective for Severe COVID-19 Patients》）

Before its approval, Olumiant was initially approved in 2018 for the treatment of rheumatoid arthritis and received Emergency Use Authorization (EUA) in November 2020 to be used in combination with Veklury, becoming one of the first drugs used to combat COVID-19. In July of last year, the U.S. FDA authorized Olumiant for use as a standalone treatment for hospitalized COVID-19 patients requiring oxygen. The medication is taken in tablet form, with a daily dose of 4mg for up to 14 days.

This time, based on the Phase III Adaptive COVID-19 Treatment Trial 2 (ACTT-2) and the COV-Barrier clinical trial, the U.S. FDA fully supported the safety and efficacy of Olumiant. Among them, the ACTT-2 trial was sponsored by the National Institute of Allergy and Infectious Diseases, while the COV-Barrier trial was sponsored by Eli Lilly and Company. Although the approved population does not include pediatric patients aged 2 to 17, this group can still receive treatment with Olumiant through Emergency Use Authorization.

During this period, the drug sales of Olumiant also showed steady growth, increasing from $427 million in 2019 to $639 million in 2020 and $1.115 billion in 2021. Just last month, Eli Lilly reported that Olumiant's first-quarter sales reached $256 million, a 32% increase from the first quarter of 2021.

Eli Lilly Senior Vice President, Eli Lilly Immunology, U.S. President and Chief Customer Officer Patrik Jonsson stated that nearly one million COVID-19 patients across approximately 15 countries or regions globally have received treatment with Olumiant (baricitinib). The full approval of Olumiant now reflects Eli Lilly's confidence in the efficacy of Olumiant for treating these hospitalized patients.

JAK Small Molecule Inhibitors Manipulate the JAK-STAT Signaling Pathway in the Human Body, and the JAK-STAT Pathway is an Ideal Target for Reducing Inflammatory Symptoms Due to Its Role in Inflammatory Responses. Typically, the Severity of COVID-19 Infection is Characterized by the Extent of the Inflammatory Response, Which Leads to Cytokine Secretion and Influences Cellular Responses to Inflammation. As the First Janus Kinase (JAK) Inhibitor Approved by the U.S. FDA, Olumiant Can Interrupt Communication in the Inflammatory Response by Interfering with Cytokine Activity.

In Japan and the European Union, Olumiant has already been approved for the treatment of atopic dermatitis. However, the development journey of Olumiant has not been smooth sailing. Since 2009, Eli Lilly and Incyte have started collaborating on Olumiant for inflammatory and autoimmune disease indications. Previously, Olumiant received additional indication approvals, including for moderate to severe active rheumatoid arthritis. However, after reviewing data from prior Phase II trials, a Phase III clinical trial for treating lupus patients was requested to be paused, and another indication for treating adult patients with moderate to severe atopic dermatitis was also rejected.

Gilead's Veklury, a competitor, previously received an EUA (Emergency Use Authorization) and ultimately gained full approval for Veklury in October 2020. In January this year, the U.S. FDA approved Veklury for the treatment of high-risk patients with mild to moderate COVID-19. Last year, its sales reached $5.6 billion. Additionally, in the early stages of the pandemic, Eli Lilly's antibody treatment drug bamlanivimab also received approval (for standalone use or combined treatment with etesevimab), but this approval has since been put on hold after regulators found the drug ineffective against the omicron variant.

Reference Source:

1、FDA converts emergency nod for Lilly's Olumiant to a full approval for hospitalized COVID patients

2、FDA Approves Lilly and Incyte's Olumiant For Hospitalized COVID-19 Patients