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CHMP recommends Olumiant for the treatment of adults with severe alopecia areata.-Eli Lilly.

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Published:21st May 2022

Eli Lilly and Company and Incyte announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for Olumiant (baricitinib) for the treatment of adults with severe alopecia areata (AA).

This opinion marks the first step toward European regulatory approval of Olumiant for patients with severe AA, and it is now referred to the European Commission for final action. If approved, Olumiant would be the first centrally-authorized oral treatment and first JAK inhibitor for patients with severe AA in the European Union. The European Commission's decision is expected in the next one to two months.

"Alopecia areata is an often-misunderstood autoimmune disease that can lead to unpredictable hair loss, ranging from bald patches to complete loss of all hair. The disease carries significant psychosocial burden and can impact patients of any race, ethnicity, or age, with many experiencing alopecia in their early to mid-20s," said Bianca Maria Piraccini, M.D., Ph.D., professor and head of the Dermatology Unit at the University of Bologna. "As there has never been a centrally-authorized therapy for alopecia areata, I'm delighted about Lilly's potential to provide this oral medicine with statistically significant and clinically meaningful Phase III clinical trial results for adults with severe alopecia areata across Europe."

The positive opinion was based on Lilly's Phase III BRAVE-AA1 and BRAVE-AA2 trials evaluating the efficacy and safety of Olumiant in 1,200 patients with severe AA, the largest Phase III clinical trial program with completed primary endpoints. Severe AA was defined as having a Severity of Alopecia Tool (SALT) score ?50 (?50% scalp hair loss). The primary endpoint was the proportion of patients achieving SALT greater than 20 (i.e., 80% or more scalp hair coverage) at Week 36. Across both studies, 1 out of 3 patients treated with Olumiant 4-mg achieved 80% or more scalp hair coverage (BRAVE-AA1=35.2% [n=99]; BRAVE-AA2=32.5% [n=76]), compared to 1 out of 20 patients (5.3%, n=10) and 1 out of 50 patients (2.6%, n=4) taking placebo in BRAVE-AA1 and BRAVE-AA2, respectively. Achievement of full regrowth or regrowth with minimal gaps in eyebrow and eyelash hair was also seen at 36 weeks with Olumiant 4-mg for 1 in 3 patients who at baseline had significant gaps or no notable eyebrows or eyelashes, as compared to patients taking placebo (BRAVE-AA1: 4-mg dose: eyebrow=31.4% [n=59]; eyelash=33.5% [n=56]; placebo: eyebrow=3.2% [n=4]; eyelash=3.1% [n=3]; BRAVE-AA2: 4-mg dose: eyebrow=34.8% [n=56]; eyelash=34.3% [n=48]; placebo: eyebrow=4.5% [n=5]; eyelash=5.6% [n=5]. Eyebrow and eyelash hair loss was evaluated using the Clinician-Reported Outcome (ClinRO) Measure for Eyebrow Hair Loss and ClinRO Measure for Eyelash Hair Loss – novel, clinically-validated tools developed by Lilly.

The Phase III BRAVE-AA clinical program also evaluated the safety profile of Olumiant and no new safety signals were observed. Few patients discontinued treatment due to adverse events (2.6% or less across both studies), and the majority of treatment-emergent adverse events were mild or moderate in severity.

Condition: Alopecia
Type: drug

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