BRIEF—AbbVie's JAK Inhibitor Rinvoq bags MHRA approval

US pharma major AbbVie says that the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has approved Rinvoq (upadacitinib), an oral JAK inhibitor, for the treatment of moderate to severe atopic dermatitis in adults and adolescents 12 years and older who are candidates for systemic therapy.

Upadacitinib is now MHRA-approved across four indications (atopic dermatitis, rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis) and studied in 16 Phase III clinical trials.

The recommended dose of upadacitinib for atopic dermatitis in adults is 15mg or 30mg once daily based on individual patient presentation, and 15mg once daily for adolescents (12-17 years of age, weighing at least 30 kg) and adults 65 and older.

Upadacitinib can be used with or without topical corticosteroids (TCS).

This approval, which follows last week’s European Commission marketing authorization

, is supported by data from one of the largest registrational Phase III programs in atopic dermatitis with more than 2,500 adults and adolescents with moderate to severe disease.