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FDA Approves Lilly's Olumiant (Baricitinib) for Pediatric Patients 12 Years of Age and Older with Severe Alopecia Areata
- The U.S. Food and Drug Administration approved Eli Lilly’s once-daily Olumiant for patients aged 12 and older with severe alopecia areata.
- The approval expands Olumiant’s U.S. label, which already covers adults with moderately to severely active rheumatoid arthritis and severe alopecia areata.
- The decision was based on 36-week data from the adolescent group in BRAVE-AA-PEDS, a Phase 3 study of pediatric patients with severe alopecia areata.
- Eli Lilly reported that the safety profile in patients aged 12 and older was consistent with that observed in adults with severe alopecia areata.
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FDA approves Lilly's Olumiant (baricitinib) for pediatric patients 12 years of age and older with severe alopecia areata
FDA approval supported by data from BRAVE-AA-PEDS, the first and largest Phase 3 study specifically designed to evaluate pediatric patients with severe alopecia areata (AA)
Eli Lilly received extended approval from the U.S. Food and Drug Regulatory Agency (FDA) for Olumiant, a medicine intended for paediatric patients 12 years of age or older suffering from severe alopecia. Exclusive material for subscribers. To have full access, access the link of the material and register.
·Rio de Janeiro, Brazil
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Coverage Details
Total News Sources19
Leaning Left4Leaning Right5Center6Last UpdatedBias Distribution40% Center
Bias Distribution
- 40% of the sources are Center
40% Center
L 27%
C 40%
R 33%
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