FDA approves Eli Lilly’s oral JAK inhibitor Olumiant for hospitalized patients with COVID-19

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FDA approves Eli Lilly’s oral JAK inhibitor Olumiant for hospitalized patients with COVID-19

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FDA approves Eli Lilly’s oral JAK inhibitor Olumiant for hospitalized patients with COVID-19

A few days ago, the U.S. Food and Drug Administration (FDA) has approved Olumiant (generic name: baricitinib, baricitinib), a collaboration between Eli Lilly and Incyte, for the treatment of hospitalized patients with COVID-19.

It only needs to be administered orally once a day. Olumiant is the first Janus kinase (JAK) inhibitor approved by the U.S. FDA for the treatment of hospitalized patients with COVID-19 who require supplemental oxygen, extracorporeal membrane oxygen (ECMO), or a ventilator.

Back in March, Eli Lilly and Incyte’s oral JAK inhibitor Olumiant, in combination with other drugs, reduced the risk of death by 13% in hospitalized patients with severe COVID-19, according to the latest results from the RECOVERY trial. (For more details, please click ” Death Risk Reduced by 13%, Eli Lilly’s Oral JAK Inhibitor Olumiant is Effective in Severe COVID-19 Patients ” )

Prior to the approval, Olumiant was initially approved for the treatment of rheumatoid arthritis in 2018 and was granted an Emergency Use Authorization (EUA) in November 2020 for the combination therapy with Veklury, becoming one of the first to combat COVID-19 one of the drugs.

Last July, the U.S. FDA authorized Olumiant to be used independently for hospitalized COVID-19 patients who need oxygen.

The drug is taken in tablet form at a daily dose of 4mg for up to 14 days.

With the Phase III Adaptive COVID-19 Therapeutic Trial 2 (ACTT-2) and the COV-Barrier clinical trial, the FDA fully supports the safety and efficacy of Olumiant.

Among them, the ACTT-2 trial was sponsored by the National Institute of Allergy and Infectious Diseases, and the COV-Barrier trial was sponsored by Eli Lilly.

Although this approval does not include pediatric patients between the ages of 2 and 17 years, this group still has access to Olumiant through an emergency use authorization.

Olumiant’s drug sales have also grown steadily during this period, from $427 million in 2019 to $639 million in 2020 and $1.115 billion in 2021. Just last month, Eli Lilly and Company reported that Olumiant’s first-quarter sales hit $256 million, up 32% from the first quarter of 2021.

In this regard, Patrik Jonsson, Lilly Senior Vice President, Lilly Immunology, U.S. President and Chief Customer Officer, said that nearly 1 million COVID-19 patients in about 15 countries or regions around the world have received Olumiant (baricitinib) treatment , the full approval of Olumiant today reflects Lilly’s confidence in Olumiant’s efficacy in treating these hospitalized patients.

Small molecule inhibitors of JAK manipulate JAK-STAT signaling in humans, and the role of the JAK-STAT pathway in inflammatory responses is an ideal target for reducing inflammatory symptoms.

Typically, the severity of COVID-19 infection is characterized by the degree of inflammatory responses that lead to the secretion of cytokines that affect the cellular response to inflammation.

As the first FDA-approved Janus kinase (JAK) inhibitor, Olumiant disrupts the communication of inflammatory responses by interfering with cytokine activity.

Olumiant is currently approved for the treatment of atopic dermatitis in Japan and the European Union.

However, Olumiant’s development has not been smooth sailing. Since 2009, Eli Lilly and Incyte have been collaborating on Olumiant in inflammatory and autoimmune disease indications.

Olumiant was previously approved for additional indications, including for moderately to severely active rheumatoid arthritis.

However, after reviewing data from previous phase II trials, one phase III trial in lupus patients was requested to be suspended, and another in adults with moderate-to-severe cases of atopic dermatitis was also rejected.

Competitor Gilead Veklury was also previously granted an EUA emergency authorization and finally received full approval from Veklury in October 2020.

In January, the U.S. FDA approved Veklury for the treatment of patients at high risk for mild to moderate COVID-19. Its sales reached $5.6 billion last year.

In addition, Eli Lilly’s antibody therapy bamlanivimab was approved early in the pandemic (either alone or in combination with etesevimab), but that approval is now 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

FDA approves Eli Lilly’s oral JAK inhibitor Olumiant for hospitalized patients with COVID-19

(source:internet, reference only)

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