The positive opinion from the Committee for Medicinal Products for Human Use (CHMP) follows results from the Phase 3 Viti-Up clinical program. In these trials, patients receiving a 15 mg daily dose of upadacitinib met co-primary endpoints at week 48, demonstrating at least 50% improvement in total body repigmentation and 75% improvement in facial repigmentation.
AbbVie's Upadacitinib Clears EU Hurdle for Vitiligo Treatment
The European Medicines Agency’s drug committee has endorsed upadacitinib for the treatment of non-segmental vitiligo in adults and adolescents. If the European Commission grants final approval, the JAK inhibitor will become the first systemic medication available for patients managing the chronic, autoimmune skin condition.
"Vitiligo is an autoimmune skin disease with high stigma and significant burden to patients with limited treatment options available," said Roopal Thakkar, AbbVie’s executive vice president of research and development. The current management of the disease focuses on stabilization and repigmentation, yet no systemic medicines are currently approved for these objectives. AbbVie reported that the safety profile observed during the studies remained consistent with previously approved indications for the drug, which is already used to treat conditions ranging from atopic dermatitis to Crohn's disease.
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