The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion on February 26, 2026 for Eli Lilly’s oral Janus‑kinase inhibitor Olumiant (baricitinib) in adolescents aged 12 to <18 with severe alopecia areata. The decision was announced the following day, confirming the drug’s expanded use beyond the adult population for which it was approved in 2022.
The BRAVE‑AA‑PEDS Phase 3 study, which enrolled 257 adolescents, showed that 42 % of participants achieved at least 80 % scalp hair coverage after 36 weeks, compared with 4.5 % in the placebo group. Additional outcomes included 36.5 % of patients reaching ≥90 % scalp coverage, 50 % experiencing significant eyebrow regrowth, and 42.9 % achieving eyelash regrowth.
These results address a significant unmet need. Severe alopecia areata can cause profound psychosocial distress in adolescents, and currently there are limited therapeutic options for this age group. Olumiant is the first JAK inhibitor approved for this indication in the EU, positioning Lilly to capture a new and sizable market segment.
Eli Lilly’s Q4 2025 financials provide context for the potential impact of this approval. The company reported revenue of $19.3 billion, up 43 % year‑over‑year, and net income of $6.6 billion, a 50 % increase. Guidance for 2026 projects revenue between $80 billion and $83 billion, driven largely by high‑growth products such as Mounjaro and Zepbound. The adolescent indication for Olumiant is expected to contribute to this growth trajectory, adding a new revenue stream and reinforcing Lilly’s immunology portfolio.
Chair and CEO David A. Ricks highlighted the company’s broader achievements, noting expanded manufacturing capacity and a commitment to reaching more patients worldwide. While no direct quote is available for this specific approval, Ricks has emphasized Lilly’s focus on delivering innovative therapies to underserved populations.
The announcement did not generate a significant market reaction, indicating that investors view the approval as a positive but incremental development within Lilly’s broader growth strategy.
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