AbbVie's upadacitinib secures positive CHMP opinion for vitiligo, first systemic option

AbbVie's upadacitinib (RINVOQ) received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use, recommending approval for adults and adolescents with non-segmental vitiligo — the first systemic medication for the chronic autoimmune disease.

"Vitiligo is an autoimmune skin disease with high stigma and significant burden to patients with limited treatment options available," Roopal Thakkar, executive vice president of research and development and chief scientific officer at AbbVie, said.

The recommendation is supported by data from the Phase 3 Viti-Up program, conducted under a single protocol encompassing two replicate studies with independent randomization and data collection. The trials randomized 614 participants with non-segmental vitiligo across 90 sites worldwide. Patients receiving upadacitinib 15 milligrams once daily met both co-primary endpoints at week 48: at least 50 percent improvement in total body repigmentation, measured by the Total Vitiligo Area Scoring Index, and at least 75 percent improvement in facial repigmentation. Key secondary endpoints, including facial repigmentation at week 24, were also achieved. The safety profile was consistent with approved indications, with no new signals detected.

Non-segmental vitiligo, the most common form affecting approximately 84 percent of patients, is marked by symmetrical depigmented patches on areas including the face, hands and feet. The condition is driven by autoimmune destruction of melanocytes and carries significant psychosocial burden, yet no systemic medicines are currently approved specifically for its treatment. Current management focuses on three goals: disease stabilization, repigmentation and maintaining repigmentation.

If the European Commission approves the drug in the coming months, upadacitinib would become the first systemic therapy specifically indicated for vitiligo, addressing a significant unmet need. The drug is already approved in the European Union for atopic dermatitis, rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis, ulcerative colitis, Crohn's disease and giant cell arteritis. AbbVie is also pursuing approval in the US, where the Food and Drug Administration is reviewing the same indication based on the same Phase 3 data.

The positive opinion strengthens AbbVie's immunology portfolio, which already treats more than 1 million patients across 19 immune-mediated diseases in more than 175 countries. Vitiligo affects an estimated 1 percent to 2 percent of the global population, representing a substantial commercial opportunity if approved. Investors will watch for the final European Commission decision, expected within the next few months, and for the FDA's regulatory determination on upadacitinib in vitiligo.

This article is for informational purposes only and does not constitute investment advice.