Eli Lilly’s Olumiant Wins FDA Approval as First Systemic Treatment for Alopecia Areata

Eli Lilly’s Olumiant (baricitinib) has won US Food and Drug Administration (FDA) approval as the first systemic treatment for severe alopecia areata (AA), an autoimmune disorder that leads to patchy baldness.

Olumiant oral tablets — in 4 mg, 2 mg and 1 mg doses taken once daily — were approved for the treatment of adults with the rare hair loss condition.

AA is commonly just called alopecia and affects more than 300,000 individuals in the US every year. According to Eli Lilly’s estimates, 147 million people worldwide have or will have alopecia and approximately 700,000 to 900,000 are currently suffering from severe disease.

AA is an autoimmune condition in which the body attacks its own hair follicles, causing hair loss.

Alopecia gained considerable attention after Will Smith’s infamous incident at the Oscars that brough attention to his wife Jada Pinkett Smith’s struggles with the condition.

Treatments for AA have been limited and largely cosmetic, such as the use of wigs and false eyelashes, or corticosteroid injections in the scalp. The Olumiant approval is therefore a big win as it helps fulfill a significant unmet need in the area.

Olumiant’s FDA approval for AA was based on trial data that showed patients who had at least 50 percent scalp hair loss for more than six months experienced at least 80 percent scalp hair coverage by week 36 of treatment.

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Olumiant is a Janus kinase (JAK) inhibitor that was first discovered by Incyte and then licensed to Eli Lilly. It blocks the activity of JAK1 and JAK2 to interfere with the JAK-STAT signaling pathway to dampen the production of inflammatory cytokines through the modulation of gene expression.

Olumiant was first approved for the treatment of rheumatoid arthritis in 2018. It later received authorization as a COVID-19 treatment for certain hospitalized adults. For rheumatoid arthritis, it is indicated for the treatment of adult patients with moderate to severe forms of the condition who have had an inadequate response to one or more tumor necrosis factor (TNF) blockers.

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The approval for AA was based on findings from two double-blind, placebo-controlled trials, BRAVE-AA1 and BRAVE-AA2, which are part of the largest Phase III AA clinical trial program completed to date evaluating the efficacy and safety of Olumiant.

The drug was evaluated in 1,200 adult patients with severe AA. Results from the trials showed that across the studies at 36 weeks, 17 to 22 percent of patients taking a 2 mg dose of Olumiant a day achieved 80 percent or more scalp hair coverage compared to three to five percent that received placebo.

In addition, 11 to 13 percent of patients who took 2 mg of Olumiant a day and 24 to 26 percent of patients that took 4 mg/day experienced 90 percent or more hair coverage compared to one to four percent of patients that got placebo.

Individuals can develop alopecia at any age, but most develop it during childhood or teenage years.