LLY Receives CHMP Approval for Broader Application of Olumiant in Treating Alopecia Areata

EMA Committee Recommends Expanded Use of Olumiant for Adolescents

Eli Lilly and Incyte have announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has issued a favorable recommendation for broadening the approval of Olumiant (baricitinib) to include adolescents aged 12 to under 18 with severe alopecia areata (AA).

The European Commission is expected to make a final decision regarding this recommendation within the next couple of months.

Lilly’s Stock Performance in 2024

So far this year, Eli Lilly’s shares have declined by 2.1%, while the broader large-cap pharmaceuticals sector has seen a gain of 5.2%.

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Details from the BRAVE-AA-PEDS Study

The positive opinion from CHMP is supported by results from the phase III BRAVE-AA-PEDS trial, which assessed the safety and effectiveness of daily oral Olumiant compared to placebo in this patient group. The findings revealed that 42% of participants with severe AA achieved at least 80% scalp hair coverage after 36 weeks of treatment. Additionally, many saw significant regrowth of eyebrows and eyelashes.

This study is notable as the first to specifically examine the effects of treatment in children and adolescents with severe AA.

According to the companies, the CHMP’s endorsement highlights Olumiant’s potential as a new therapeutic option for young people affected by alopecia areata, a chronic autoimmune disorder that can have a profound impact on quality of life.

About Olumiant: A JAK Inhibitor from Lilly and Incyte

Olumiant, an oral JAK inhibitor developed by Incyte and licensed to Eli Lilly, is already approved for several autoimmune conditions, including severe AA in adults.

Lilly is also seeking regulatory approval in the United States for Olumiant’s use in adolescents with severe AA, with a decision anticipated in the latter half of 2026.

Incyte receives royalties from Lilly based on Olumiant sales.

In 2025, Olumiant generated $1.01 billion in revenue for Lilly and Incyte. Expanding the drug’s approved uses could further boost sales in the coming years.

Zacks Rankings and Other Biotech Stocks to Watch

Currently, Eli Lilly holds a Zacks Rank #3 (Hold).

Other biotech companies with higher Zacks rankings include Castle Biosciences (CSTL) and ANI Pharmaceuticals (ANIP). Castle Biosciences is rated Zacks Rank #1 (Strong Buy), while ANI Pharmaceuticals holds a Zacks Rank #2 (Buy).

• Castle Biosciences has seen its projected loss per share for 2026 improve from $1.06 to $0.96, and for 2027 from $0.76 to $0.61, over the past two months. However, CSTL shares have dropped 24% year-to-date.
• The company exceeded earnings expectations in three of the last four quarters, with an average earnings surprise of 34.69%.
• ANI Pharmaceuticals’ earnings estimates for 2026 have risen from $8.08 to $8.22, and for 2027 from $9.25 to $9.90, in the past 60 days. ANIP shares are down 6.4% year-to-date.
• ANI Pharmaceuticals has surpassed earnings estimates in each of the last four quarters, averaging a 22.21% earnings surprise.

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Free Stock Analysis Reports

• Eli Lilly and Company (LLY): Free Stock Analysis Report
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