AbbVie Earns CHMP Nod for Upadacitinib After Successful Phase 3 Hair Regrowth Trials
ABBV•AbbVie received a positive CHMP opinion recommending upadacitinib 15 mg and 30 mg for severe alopecia areata in adults and adolescents based on Phase 3 UP-AA results. Both replicate 24-week trials met the primary SALT ≤20 endpoint and showed complete scalp hair regrowth, with EU approval decision expected within months.
1. CHMP Positive Opinion
The EMA’s Committee for Medicinal Products for Human Use adopted a positive opinion for upadacitinib 15 mg and 30 mg once daily in adults and adolescents with severe alopecia areata, marking a key regulatory milestone ahead of the final European Commission decision expected in the coming months.
2. Phase 3 UP-AA Trial Results
Two replicate, randomized, double-blind, placebo-controlled Phase 3 studies enrolled 1 399 participants aged 12 to 64 across 248 sites, with both 15 mg and 30 mg doses meeting the primary endpoint of SALT score ≤ 20 at week 24 and achieving complete scalp hair regrowth (SALT = 0) as a ranked secondary endpoint.
3. Safety Profile
The safety profile of both doses during the initial 24-week period was consistent with results in approved indications, with no new safety signals reported in severe alopecia areata patients.
4. Next Steps and Market Impact
Final European Commission approval is anticipated within months, potentially expanding AbbVie's RINVOQ label into a new indication and addressing an underrecognized alopecia areata market, which could deliver incremental revenue growth in the EU.
