AbbVie has announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending approval of upadacitinib (RINVOQ) for two autoimmune conditions — severe alopecia areata and non-segmental vitiligo.
The recommendation covers once-daily upadacitinib 15 mg and 30 mg doses for adult and adolescent patients with severe alopecia areata, while the 15 mg once-daily dose has been recommended for adult and adolescent patients with non-segmental vitiligo. A final decision from the European Commission is expected in the coming months.
Positive Opinion for Severe Alopecia Areata
Alopecia areata is an autoimmune condition that causes a range of hair loss patterns from sudden, round bald patches on the scalp to complete loss of all body hair, including scalp, face, eyebrows and eyelashes. Although driven by immune dysfunction, it is often perceived as a cosmetic problem, which can lead to stigma and affect patients’ emotional wellbeing and quality of life.
Roopal Thakkar, executive vice president, research and development and chief scientific officer at AbbVie, said the condition remains unpredictable and its burden on patients is frequently underestimated.
“The CHMP’s positive opinion for upadacitinib is a step closer to bringing a new treatment option to patients living with severe alopecia areata,” she said.
The recommendation is supported by results from AbbVie’s ongoing Phase 3 UP-AA clinical programme, which includes two replicate randomised, placebo-controlled, double-blind studies in adults and adolescents with severe alopecia areata.
Both the 15 mg and 30 mg doses met the primary endpoint at week 24, with significantly more patients achieving at least 80 per cent scalp hair coverage compared with placebo. Patients also showed improvements in complete scalp hair regrowth.
Potential First Systemic Treatment for Non-segmental Vitiligo
If approved, upadacitinib could become the first systemic medication for patients with non-segmental vitiligo.
Vitiligo is a chronic autoimmune skin disease characterized by the loss of pigment-producing cells (melanocytes), resulting in white patches that may appear anywhere on the body. Non-segmental vitiligo accounts for approximately 84 per cent of cases and is marked by symmetrical and bilateral depigmented white patches that can progress unpredictably over time. Beyond the visible symptoms, the condition can significantly affect confidence, identity and day-to-day life.
Thakkar said Vitiligo carries a high level of stigma and places a significant burden on patients, while treatment options remain limited.
The CHMP recommendation is based on data from the ongoing Phase 3 Viti-Up clinical programme, which includes two replicate placebo-controlled studies in adult and adolescent patients with non-segmental vitiligo. Upadacitinib 15 mg achieved both co-primary endpoints and key secondary endpoints, demonstrating significant improvements in facial and total body repigmentation.
About RINVOQ (Upadacitinib)
RINVOQ (upadacitinib) is a Janus kinase (JAK) inhibitor discovered and developed by AbbVie to treat immune-mediated inflammatory diseases. The medicine is currently being investigated in Phase 3 studies across several conditions, including alopecia areata, hidradenitis suppurativa, Takayasu arteritis, systemic lupus erythematosus and vitiligo.
In the European Union, upadacitinib is already approved for multiple conditions, including atopic dermatitis, radiographic axial spondylarthritis, non-radiographic axial spondylarthritis, rheumatoid arthritis, psoriatic arthritis, Crohn’s disease, ulcerative colitis and giant cell arteritis.
