AbbVie Announces European Commission Approval of RINVOQ® (upadacitinib) for the Treatment of Adults and Adolescents with Non-Segmental Vitiligo

RINVOQ is the first and only systemic medication approved in the European Union to treat adult and adolescent patients with non-segmental vitiligo (NSV).

The approval is supported by data from the Phase 3 Viti-Up clinical program, which showed that RINVOQ achieved statistically significant total body (T-VASI 50) and facial repigmentation (F-VASI 75) from baseline at week 48, versus placebo.

AbbVie (NYSE: ABBV) today announced that the European Commission (EC) has approved RINVOQ ® (upadacitinib; 15 mg, once daily) for the treatment of adult and adolescent patients 12 years and older with non-segmental vitiligo (NSV) who are candidates for systemic therapy.

With this approval, RINVOQ is now the first and only systemic medication approved in the European Union for NSV, the most common form of vitiligo.

Vitiligo is a chronic autoimmune disease characterized by irregular white patches on the skin, resulting from the selective destruction of melanocytes – the cells responsible for skin pigmentation. Non-segmental vitiligo (NSV) is the most common type, accounting for 84% of all vitiligo cases.

Vitiligo should not be dismissed as a cosmetic disease, as its effects can be psychologically devastating, often posing a considerable burden on patients' quality of life and resulting in high rates of depression and anxiety.

The unpredictable course of vitiligo, which might progress at any time, and the associated fear of having new and/or expanding vitiligo lesions even after long periods of stability, contribute to the burden of patients living with the disease.

The EC approval of RINVOQ is supported by data from the Phase 3 Viti-Up clinical program (M19-044), including two replicate, randomized, placebo-controlled, double-blind studies evaluating the efficacy and safety of RINVOQ in adult and adolescent patients with NSV.

As previously reported in both studies, RINVOQ 15 mg met both co-primary endpoints with statistically significant and clinically meaningful improvements in total body (T-VASI 50) and facial repigmentation (F-VASI 75) at week 48 versus placebo.

RINVOQ met key ranked secondary endpoints, including stabilization of disease extent as assessed by T-VASI in patients with actively progressing disease at baseline.

The safety profile of RINVOQ in both studies was generally consistent with that observed in approved indications, with no new safety signals.

RINVOQ is also approved in the European Union for the treatment of adults and adolescents with atopic dermatitis, and adults with radiographic axial spondylarthritis, non-radiographic axial spondylarthritis, psoriatic arthritis, rheumatoid arthritis, ulcerative colitis, Crohn's disease, and giant cell arteritis, and adults and adolescents with severe alopecia areata.