FDA Expands Treatment Eligibility
The U.S. Food and Drug Administration (FDA) has approved Eli Lilly’s Olumiant (baricitinib) for patients aged 12 years and older with severe alopecia areata. The approval expands the drug’s existing use in adults with the condition.
Alopecia areata is an immune-related disorder that causes unpredictable hair loss. It often begins early in life and can significantly affect adolescents.
Clinical Trial Shows Hair Regrowth
The FDA based its decision on results from the Phase 3 BRAVE-AA-PEDS trial, which evaluated Olumiant in pediatric patients with severe alopecia areata.
After 36 weeks, 42% of patients receiving 4 mg of Olumiant achieved at least 80% scalp hair coverage, compared with 27% receiving 2 mg and 5% receiving placebo. The treatment also improved eyebrow and eyelash coverage in eligible patients.
As per PR Newswire, the FDA approval provides another treatment option for adolescents living with severe alopecia areata. The company highlighted the importance of addressing extensive hair loss during adolescence.
Dosage and Safety
The recommended starting dose for pediatric patients is 2 mg once daily, with an increase to 4 mg possible when the response remains inadequate. However, Olumiant carries an FDA boxed warning for serious infections, malignancies, major cardiovascular events and thrombosis.