FDA Expands Olumiant Label to Adolescents With Severe Alopecia
LLY sits 66% above its 52-week low of $712.05.
Summary
The FDA expanded the label for Lilly's Olumiant (baricitinib) to include patients 12 and older with severe alopecia areata, based on Phase 3 data. In the BRAVE-AA-PEDS Phase 3 trial, 42% of adolescents on 4 mg achieved 80% or greater scalp hair coverage at 36 weeks, versus 27% on 2 mg and 5% on placebo. Recommended dosing starts at 2 mg daily, escalating to 4 mg if needed. This broadens the drug's addressable market beyond adults and adds a pediatric indication in a disease with high unmet need. The approval reinforces Lilly's immunology franchise and follows a string of positive regulatory and pipeline developments this year. While Olumiant is not a top revenue driver compared to Mounjaro/Zepbound, the label expansion is a meaningful incremental positive for the company's diversified portfolio.
Updated with a Benzinga report · What changed
Updates
· Benzinga — In the BRAVE-AA-PEDS Phase 3 trial, 42% of adolescents on 4 mg achieved 80% or greater scalp hair coverage at 36 weeks, versus 27% on 2 mg and 5% on placebo. Recommended dosing starts at 2 mg daily, escalating to 4 mg if needed.
At the time of this announcement, LLY was trading at $1,183.99 on NYSE in the Life Sciences sector, with a market capitalization of approximately $1.1T. The 52-week trading range was $712.05 to $1,292.65. This news item was assessed with positive market sentiment and an importance score of 7 out of 10. Source: Dow Jones Newswires.