AbbVie has cleared a major regulatory milestone after the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion for approval of upadacitinib for adults and adolescents with severe alopecia areata (AA). 

 

A final decision from the European Commission is expected in the coming months.

 

"Alopecia areata is an unpredictable autoimmune disease with underrecognized patient burden," said Roopal Thakkar, executive vice president, research and development, chief scientific officer, AbbVie. "The CHMP's positive opinion for upadacitinib is a step closer to bringing a new treatment option to patients living with severe alopecia areata."

 

The recommendation is backed by results from AbbVie's ongoing Phase 3 UP-AA clinical program (M23-716), which includes two replicate randomized, placebo-controlled, double-blind studies assessing upadacitinib in adults and adolescents with severe alopecia areata.

 

In both trials, the 15 mg and 30 mg doses met the primary endpoint at week 24, with significantly more patients achieving at least 80% scalp hair coverage compared with placebo. Both doses also met key secondary endpoints, including complete scalp hair regrowth at week 24. 

 

The safety profile during the study remained generally consistent with that seen across the drug's previously approved indications.

 

RINVOQ is already approved in the European Union for multiple inflammatory conditions, including atopic dermatitis in adults and adolescents, as well as rheumatoid arthritis.