AbbVie has announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the approval of upadacitinib (RINVOQ [15 mg, once daily]) for the treatment of adult and adolescent patients with non-segmental vitiligo (NSV).
The final European Commission decision is expected in the coming months.
If approved, upadacitinib is expected to be the first systemic medication for patients with non-segmental vitiligo.
"Vitiligo is an autoimmune skin disease with high stigma and significant burden to patients with limited treatment options available," said Roopal Thakkar, Executive Vice President, Research and Development, Chief Scientific Officer, AbbVie.
"A positive opinion for upadacitinib in non-segmental vitiligo is an important step forward in providing patients with a systemic treatment option."
The CHMP positive opinion is supported by data from the ongoing Phase III Viti-Up clinical programme, including two replicate, randomised, placebo-controlled, double-blind studies evaluating the efficacy and safety of upadacitinib in adult and adolescent patients with NSV.
Upadacitinib 15 mg met both coprimary endpoints and key secondary endpoints, with significant improvements in total body and facial repigmentation.
The safety profile of upadacitinib 15 mg was consistent with that observed in approved indications, with no new safety signals.
Upadacitinib is approved in the European Union (EU) for the treatment of adults and adolescents with atopic dermatitis and adults with radiographic axial spondyloarthritis, non-radiographic axial spondyloarthritis, psoriatic arthritis, rheumatoid arthritis, ulcerative colitis, Crohn's disease and giant cell arteritis.
Use of upadacitinib in NSV is not currently approved in the EU.
