New treatment for alopecia areata in adults and adolescents moves closer to EU approval after CHMP recommendation
Positive opinion is based on Phase III trial results showing significant scalp hair regrowth, with a final European Commission decision expected in the coming months.
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending approval of AbbVie’s upadacitinib for the treatment of adults and adolescents with severe alopecia areata, the company announced.
If approved by the European Commission, upadacitinib, marketed as RINVOQ, would become available in 15 mg and 30 mg once-daily doses for patients with severe alopecia areata. The European Commission is expected to make a final decision in the coming months.
Alopecia areata is an autoimmune condition in which the immune system mistakenly attacks hair follicles, causing hair loss that can range from small bald patches on the scalp to complete loss of scalp and body hair, including eyebrows and eyelashes.
The CHMP recommendation is based on data from the ongoing Phase III UP-AA clinical programme. A Phase III clinical trial is a late-stage study designed to evaluate the effectiveness and safety of a treatment in a large group of patients before regulatory approval is considered.
According to AbbVie, the programme comprises two randomised, placebo-controlled, double-blind studies evaluating upadacitinib in adults and adolescents with severe alopecia areata. In such studies, participants are randomly assigned to receive either the investigational treatment or a placebo, and neither the participants nor the researchers know which treatment each participant receives until the study is completed.
Both the 15 mg and 30 mg doses met the primary study endpoint at 24 weeks. Significantly more patients receiving upadacitinib achieved a Severity of Alopecia Tool (SALT) score of 20 or lower compared with placebo, indicating at least 80% scalp hair coverage.
The company also said both doses met key secondary endpoints, including improvements in eyebrows and eyelashes and complete scalp hair regrowth, defined as a SALT score of zero, at week 24. AbbVie said upadacitinib is the first Janus kinase (JAK) inhibitor to meet the ranked secondary endpoint of complete scalp hair regrowth at week 24 in the programme.
JAK inhibitors are medicines that block enzymes involved in immune system signalling and are used to treat several immune-mediated conditions.
“The CHMP’s positive opinion for upadacitinib is a step closer to bringing a new treatment option to patients living with severe alopecia areata,” said Dr Roopal Thakkar, executive vice president, research and development, and chief scientific officer at AbbVie.
Thakkar said alopecia areata is “an unpredictable autoimmune disease with underrecognised patient burden”.
AbbVie said the safety profile of both doses during the first 24 weeks of the studies was generally consistent with that observed in the medicine’s approved indications.
The company said upadacitinib is already approved in the European Union for several immune-mediated conditions, including atopic dermatitis, rheumatoid arthritis, psoriatic arthritis, ulcerative colitis, Crohn’s disease, radiographic and non-radiographic axial spondylarthritis, and giant cell arteritis. However, its use for alopecia areata has not yet been approved in the European Union.
