Upadacitinib hemihydrate

AbbVie announced Wednesday that the European Commission authorised twin label expansions for Rinvoq (upadacitinib), clearing the oral JAK inhibitor to treat adult and adolescent patients aged 12 years and older with non-segmental vitiligo (NSV), and separately for severe alopecia areata (AA).Roopal Thakkar, chief scientific officer at AbbVie, said "approval of Rinvoq as the first and only systemic treatment for [NSV] is an advancement for patients living with this chronic autoimmune disease." On the second approval, Thakkar added that it "provides another option for patients who continue to navigate physical and mental burden associated with severe [AA], often overlooked due to stigma."The NSV clearance is backed by data from the Phase III Viti-Up clinical programme, comprising two replicate trials. Results showed Rinvoq met both co-primary endpoints, achieving statistically significant and clinically meaningful total body repigmentation (T-VASI 50) and facial repigmentation (F-VASI 75) from baseline at week 48 compared with placebo. The therapy also met key ranked secondary endpoints, including stabilisation of disease extent in patients with actively progressing disease at baseline.Meanwhile, the drug's marketing application for NSV remains under FDA review, with a decision expected later this year.In parallel, Rinvoq's AA indication was supported by the ongoing Phase III UP-AA programme — also comprising two replicate studies — in which the JAK inhibitor at both 15 mg and 30 mg doses significantly outperformed placebo on the primary goal of achieving ≥80% scalp hair coverage at week 24; key secondary endpoints, including complete scalp hair regrowth were also met.The AbbVie drug is previously approved in the EU for multiple indications, including atopic dermatitis, rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis, ulcerative colitis, Crohn's disease and giant cell arteritis.Rinvoq — having generated $2.1 billion in global revenues in the first quarter — remains a key sales driver for the company, which raised the full-year 2026 sales guidance for the product to $10.1 billion.