Eli Lilly’s Olumiant (baricitinib) has received FDA approval as a once-daily pill to treat paediatric patients 12 years of age and older with severe hair loss (alopecia areata) (AA). The approval builds on Olumiant’s established use in adults with moderately to severely active rheumatoid arthritis and severe alopecia areata (AA).
AA is a chronic immune-mediated disease that causes unpredictable hair loss. As many as 2% of people develop AA at some point in their lives, and nearly 40% of cases occur before the age of 20. Early-onset AA can be more severe and lead to extensive hair loss.
“Today’s approval marks an important milestone for young people living with severe alopecia areata and their families, who have had limited treatment options to date,” said Adrienne Brown, executive vice president and president, Lilly Immunology. “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.”
The FDA approval is based on 36-week data from the adolescent cohort (ages 12 to under 18) of BRAVE-AA-PEDS, the first and largest phase 3 study specifically designed to evaluate pediatric patients with severe AA. At baseline, the median Severity of Alopecia Tool (SALT) score was 100, indicating complete scalp hair loss, and patients had been living with AA for a mean of 6.4 years.
At Week 36, treatment with once-daily Olumiant delivered:
- 80% or more scalp hair coverage, as measured by a SALT score ≤20, in 42% of patients treated with Olumiant 4 mg and 27% treated with Olumiant 2 mg, compared with 5% receiving placebo.
- 90% or more scalp hair coverage, as measured by a SALT score ≤10, in 37% of patients treated with Olumiant 4 mg and 21% treated with Olumiant 2 mg, compared with 2% receiving placebo.
- Improved eyebrow and eyelash coverage among patients with substantial eyebrow and eyelash hair loss at baseline treated with Olumiant 4 mg.
The overall safety profile observed in paediatric patients 12 years of age and older with severe AA is consistent with the safety profile in adults with severe AA. The FDA-approved labelling for Olumiant includes a boxed warning for risk of serious infections, mortality, malignancy, major adverse cardiovascular events (MACE) and thrombosis.
In 2022, the FDA approved Olumiant for adult patients with severe AA, making it the first systemic treatment approved in the US for this condition. In April 2026, the European Commission also approved Olumiant for the treatment of adolescents (ages 12 to under 18) with severe AA.