Eli Lilly and Incyte announced that the U.S. Food and Drug Administration (FDA) approved Olumiant (baricitinib) for adult patients with severe alopecia areata. The recommended dose of Olumiant was 2 mg/day; however, it can be increased to 4 mg/day if required. 4 mg/day was recommended in patients with complete or nearly complete scalp hair loss, with or without eyelash or eyebrow hair loss. Olumaint should not be administered in combination with other JAK inhibitors, biologic immunomodulators, cyclosporine, or immunosuppressants.
The FDA approval was based on BRAVE-AA1 and BRAVE-AA2 trials. The trials included 1,200 adult patients with severe alopecia areata.
Among the patients with eyebrow and eyelash hair loss at baseline, improvements were observed in patients administered with Olumiant 4 mg/day at 36 weeks.
Few patients discontinued because of the adverse events.
Eli Lilly is expecting approvals in Europe and Japan for Oluminat in alopecia areata in 2022.
Olumiant is approved for moderately to severely active rheumatoid arthritis and hospitalized adult COVID19 patients requiring supplemental oxygen.