Eli Lilly and Incyte Receive CHMP Positive Opinion of Olumiant (baricitinib) for the Treatment of Adults with Severe Alopecia Areata
Shots:
- The opinion was based on P-III (BRAVE-AA1 & 2) trials evaluating Olumiant (4mg) vs PBO in 1200 patients with sev. AA. The 1EPs was the proportion of patients who achieved SALT ≤20 @36wk. In both studies, patients achieved ≥80% scalp hair coverage (35.2% & 32.5%) vs (5.3% & 2.6%)
- In (BRAVE-AA1) study, patients achieved full regrowth or regrowth with minimal gaps in eyebrow & eyelash hair (31.4% vs 3.2% & 33.5% vs 3.1%) while in (BRAVE-AA2) study (34.8% vs 4.5% & 34.3% vs 5.6%) with no new safety signals, AEs lead to discontinued treatment (≤2.6%) in both studies
- If Olumiant is approved, it will be 1st centrally-authorized oral treatment & 1st JAK inhibitor for sev. AA in the EU with an expected EC decision in the next 1 to 2mos.
Ref: PRNewswire | Image: Incyte
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