AbbVie's RINVOQ could become first systemic vitiligo treatment in Europe

AbbVie has announced a positive opinion from the European Medicines Agency’s CHMP for upadacitinib (RINVOQ) in treating non-segmental vitiligo. The drug could become the first systemic medication approved for this condition if the European Commission grants final approval. Vitiligo is a chronic autoimmune disease causing white patches on the skin due to pigment cell loss. The CHMP’s decision is based on results from the Phase 3 Viti-Up clinical programme. Two replicate, randomised, placebo-controlled, double-blind studies showed upadacitinib 15 mg met both co-primary and key secondary endpoints. Patients experienced significant improvements in total body and facial repigmentation.

RINVOQ is a JAK inhibitor developed by AbbVie, with greater potency against JAK-1 compared to JAK-2, JAK-3, and TYK-2. It is already approved in the EU for several conditions, including rheumatoid arthritis, psoriatic arthritis, and atopic dermatitis. Common side effects in trials included infections, elevated liver enzymes, and increased cholesterol levels.

Non-segmental vitiligo affects about 84% of patients, causing symmetrical depigmented patches. The drug is not suitable for patients with active tuberculosis, serious infections, severe liver impairment, or during pregnancy. If approved, upadacitinib will offer a new systemic treatment option for adult and adolescent patients with non-segmental vitiligo. The decision marks a potential milestone for those living with the condition. Final approval now rests with the European Commission.