FDA clears Lilly’s Olumiant for teens with severe alopecia areata
Eli Lilly and Company (LLY) said the U.S. Food and Drug Administration approved Olumiant (baricitinib) as a once-daily oral treatment for patients 12 years of age and older with severe alopecia areata (AA), expanding the drug’s existing U.S. label beyond adult use.
The approval is based on 36-week data from the BRAVE-AA-PEDS Phase 3 trial, which enrolled adolescents ages 12 to under 18. 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, 42% of patients receiving Olumiant 4 mg and 27% receiving Olumiant 2 mg achieved at least 80% scalp hair coverage, compared with 5% in the placebo group. At least 90% scalp hair coverage was achieved by 37% of patients on 4 mg and 21% on 2 mg, versus 2% on placebo. Patients treated with the 4 mg dose also showed improved eyebrow and eyelash coverage.
The recommended starting dose is 2 mg per day, with an option to increa
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