FDA approves Lilly's Olumiant for adolescents with alopecia

The US Food and Drug Administration approved Eli Lilly and Company's once-daily pill Olumiant (baricitinib) for pediatric patients aged 12 and older with severe alopecia areata. The decision expands Olumiant's US label beyond its existing indications in adults with severe alopecia areata and moderately to severely active rheumatoid arthritis.

The approval was based on 36-week data from the adolescent cohort of the Phase 3 BRAVE-AA-PEDS study. At baseline, patients had lived with the condition for an average of 6.4 years, and the median Severity of Alopecia Tool score was 100, indicating complete scalp hair loss. By week 36, 42% of patients taking Olumiant 4 mg and 27% taking 2 mg achieved 80% or more scalp hair coverage, compared to 5% on placebo. In addition, 37% on 4 mg and 21% on 2 mg reached 90% or more coverage, versus 2% for placebo.

The safety profile in pediatric patients aged 12 and older was consistent with that seen in adults. The US labeling retains a boxed warning for risks of serious infections, mortality, malignancy, major adverse cardiovascular events, and thrombosis. Olumiant was originally discovered by Incyte and licensed to Lilly under a December 2009 agreement. More than 33,000 patients have been prescribed the drug in the US since 2017.