Eli Lilly-Incyte Partnered FDA-Approved Drug Shows Encouraging Efficacy In Adolescent Patients With Patchy Hair Loss

On Saturday, Eli Lilly And Co LLY and Incyte Corporation INCY said adolescent patients with severe alopecia areata (AA) treated with once-daily oral baricitinib 4 mg and 2 mg saw clinically meaningful improvements in hair regrowth on the scalp, eyebrows, and eyelashes at Week 36.

Findings from the Phase 3 BRAVE-AA-PEDS study were presented at the American Academy of Dermatology.

AA is an immune system condition that causes patchy hair loss on the scalp, face, and sometimes other body areas, which can progress over time.

At Week 36:

• 60.0% of patients receiving baricitinib 4 mg and 36.9% of patients receiving baricitinib 2 mg saw at least a 50% improvement in their disease compared to 5.7% on placebo.
• 42.4% of patients receiving baricitinib 4 mg and 27.4% receiving baricitinib 2 mg achieved 80% or more scalp hair coverage, compared to 4.5% on placebo.
• 36.5% of patients receiving baricitinib 4 mg and 21.4% of patients receiving baricitinib 2 mg had 90% or more scalp hair coverage compared to 2.3% on placebo.
• 50.0% of patients receiving baricitinib 4 mg and 24.1% of patients receiving baricitinib 2 mg achieved significant eyebrow regrowth compared to 0% on placebo.
• 42.9% of patients receiving baricitinib 4 mg achieved significant eyelash regrowth, and 25.5% receiving baricitinib 2 mg saw improved eyelash regrowth, compared to 14.0% on placebo.

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Results achieved by adolescents at 36 weeks were comparable to those achieved by adults after 52 weeks of treatment, suggesting that hair regrowth may be faster in adolescents than in adults.

In the BRAVE-AA1 and BRAVE-AA2 studies, 40.9% of adult patients treated with baricitinib 4 mg and 21.2% of patients treated with baricitinib 2 mg achieved 80% or more scalp hair coverage at Week 52.

In 2022, the U.S. Food and Drug Administration (FDA) approved baricitinib, also known as Olumiant, for adult patients with severe AA.

Price Action: LLY stock is down 0.57% at $825.01, and INCY stock is up 0.89% at $71.76 during the premarket session at the last check Tuesday.

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