INDIANAPOLIS (dpa-AFX) - Eli Lilly and Company (LLY) announced that the U.S. Food and Drug Administration approved Olumiant (baricitinib) for the treatment of severe alopecia areata in pediatric patients aged 12 years and older, extending the medicine's use beyond adults.
The approval broadens Olumiant's U.S. label and adds to its existing indications, which include treatment of adults with severe alopecia areata and moderately to severely active rheumatoid arthritis.
Alopecia areata is a chronic immune-mediated disorder that causes unpredictable hair loss and can significantly affect patients' quality of life.
The FDA's decision was supported by results from BRAVE-AA-PEDS, the first and largest Phase 3 clinical trial designed specifically to assess the safety and effectiveness of a treatment in adolescents with severe alopecia areata.
Olumiant, a once-daily oral Janus kinase (JAK) inhibitor discovered by Incyte and licensed to Lilly, is available through specialty pharmacies across the United States. The drug is offered in 1 mg, 2 mg and 4 mg tablet strengths.
According to the approved prescribing information, the recommended starting dose for eligible patients is 2 mg once daily. The dosage may be increased to 4 mg daily if the response is inadequate. Patients with nearly complete or complete scalp hair loss, including those with substantial eyebrow or eyelash loss, may begin treatment at the 4 mg dose. Once sufficient improvement is achieved, treatment can be reduced to 2 mg daily.
The FDA-approved labeling for Olumiant carries a boxed warning highlighting risks including serious infections, mortality, malignancies, major adverse cardiovascular events and thrombosis.
Olumiant first received FDA approval in 2022 for adults with severe alopecia areata. More recently, the European Commission approved the therapy for adolescents aged 12 to under 18 years with severe alopecia areata in April 2026.
Beyond alopecia areata, baricitinib is approved in the United States and more than 75 countries for adults with moderately to severely active rheumatoid arthritis. The medicine is also authorized in the U.S. for hospitalized adults with COVID-19 and is approved for severe alopecia areata in adults and adolescents in several major markets, including the European Union and Japan.
Lilly and Incyte entered into an exclusive worldwide licensing and collaboration agreement in December 2009 to develop and commercialize Olumiant and related compounds for inflammatory and autoimmune diseases.
LLY closed Friday's regular trading at $1,183.46 up $1.57 or 0.13%.
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