The US Food and Drug Administration (FDA) has approved Eli Lilly’s Olumiant (baricitinib), a once-daily pill, for the treatment of paediatric patients aged 12 years and older with severe alopecia areata (AA).
Baricitinib is already approved in the US for use in adults with moderately to severely active rheumatoid arthritis and severe AA.
A chronic immune-mediated disease, alopecia areata causes unpredictable hair loss. It is estimated that up to 2% of people develop the condition at some point in their lives, with nearly 40% of cases occurring before the age of 20.
Adrienne Brown, executive vice president and president, Lilly Immunology, welcomed the FDA approval, describing it as an important milestone for young people living with severe alopecia areata and their families, who have had limited treatment options to date.
“The visible and often extensive hair loss that comes with severe alopecia areata can have a profound impact on anyone, especially adolescents who are at a pivotal stage of life. Expanding Olumiant to patients as young as 12 provides them a much-needed treatment choice and reinforces our commitment to advancing care for people living with immune-mediated diseases,” Brown said.
The FDA approval is based on 36-week results from the adolescent cohort of the Phase 3 BRAVE-AA-PEDS trial, which evaluated Olumiant in patients aged 12 to under 18 with severe alopecia areata. At baseline, patients had a median Severity of Alopecia Tool (SALT) score of 100, indicating complete scalp hair loss, and had lived with the condition for an average of 6.4 years.
By Week 36, 42% of patients receiving Olumiant 4 mg and 27% receiving 2 mg achieved at least 80% scalp hair coverage, compared with 5% on placebo. At least 90% scalp hair coverage was achieved by 37% and 21% of patients in the 4 mg and 2 mg groups, respectively, versus 2% with placebo.
Olumiant 4 mg also improved eyebrow and eyelash coverage among patients with substantial hair loss in these areas at baseline.
Olumiant is available in 4 mg, 2 mg and 1 mg tablets. The recommended dose is 2 mg once daily, with an increase to 4 mg once daily if the treatment response is inadequate. For patients with nearly complete or complete scalp hair loss, with or without substantial eyebrow or eyelash hair loss, treatment with 4 mg once daily may be considered, Lily said.
Once an adequate response is achieved with 4 mg, the dose should be reduced to 2 mg once daily, the company noted.
Olumiant is a once-daily oral Janus kinase (JAK) inhibitor discovered by Incyte and licensed to Lilly. In December 2009, Lilly and Incyte entered into an exclusive worldwide licence and collaboration agreement for the development and commercialisation of Olumiant and certain follow-on compounds for the treatment of inflammatory and autoimmune diseases.
Baricitinib is approved in the US and more than 75 countries as a treatment for adults with moderately to severely active rheumatoid arthritis.
In 2022, the US FDA approved Olumiant for adult patients with severe alopecia areata, making it the first systemic treatment approved in the US for the condition. Olumiant is also approved in the US for the treatment of hospitalised adults with COVID-19.
In April 2026, the European Commission approved Olumiant for the treatment of adolescents aged 12 to under 18 with severe AA.
Olumiant is also approved in the US, European Union and Japan for adults and paediatric patients aged 12 years and older with severe AA.
