Eli Lilly and Company’s Olumiant (baricitinib) has been recommended for approval in Europe for adolescents with severe alopecia areata (AA). Incyte first discovered the Janus kinase (JAK) inhibitor, then licensed it to Lilly.

What Alopecia Areata Is

AA is an autoimmune disease that attacks hair follicles, causing hair loss potentially anywhere on the body. However, it usually primarily affects the head and face. Hair falls out in small, round (approximately quarter-sized) patches.

Early-onset AA can be more severe, according to Lilly, and potentially lead to extensive and unpredictable hair loss.

The positive opinion comes from the European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP). Included in this indication are adolescents from age 12 up to 18.

36-week data from a Phase III trial (BRAVE-AA-PEDS) informed CHMP’s decision. According to that study, many adolescent patients achieved near-complete scalp hair regrowth. Others experienced successful eyebrow and eyelash regrowth.

Olumient History and Lilly Response

The European Commission and U.S. FDA both approved Olumiant in 2022 for treatment of severe AA in adults.

Anabela Cardoso, senior vice president, Lilly Immunology Medical Affairs, applauded the potential expansion of the once-daily oral treatment.

Cardoso said the recommendation will impact adolescents “living with the profound physical and emotional realities of severe alopecia areata.”

Thierry Passeron, MD, PhD, professor and chair, Department of Dermatology, Université Côte d’Azur, agreed, saying emotional well-being is at stake.

“Adolescents with severe alopecia areata represent a particularly vulnerable population,” Passeron said. “[AA] is difficult to manage and occurs at a time when appearance can have a significant impact on social identity.”

A decision by the European Commission on CHMP’s recommendation is expected in the next one to two months.