AbbVie announced the European Commission (EC) approved Rinvoq (upadacitinib), an oral, selective and reversible 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. The recommended dose of Rinvoq for atopic dermatitis in adults is 15 mg or 30 mg once daily based on individual patient presentation, and 15 mg once daily for adolescents (12-17 years of age) and adults 65 years and older. Rinvoq can be used with or without topical corticosteroids (TCS).
“This is a significant milestone for AbbVie in our pursuit to transform care in atopic dermatitis,” said Michael Severino, M.D., vice chairman and president, AbbVie. “We are excited to provide an additional treatment option in Europe to help alleviate the burden of unrelenting itch and rash that many of these patients struggle with in daily life, despite available treatment options.”
The EC approval is supported by data from one of the largest registrational phase 3 programs in atopic dermatitis with more than 2,500 adults and adolescents with moderate to severe disease. These studies evaluated the efficacy and safety of Rinvoq monotherapy (Measure Up 1 [MU1] and Measure Up 2 [MU2]) and with topical corticosteroids (AD Up [AU]) compared to placebo. In all three studies, the co-primary endpoints were at least a 75 percent improvement in the Eczema Area and Severity Index (EASI 75) and validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD) score of 0/1 (clear or almost clear) at week 16.
“As a dermatologist researching and treating atopic dermatitis for more than 25 years, I've seen first-hand the debilitating impact this disease can have on a person's daily life,” said Alan Irvine, M.D., D.Sc., professor of dermatology, Trinity College Dublin, Ireland, and Rinvoq clinical study investigator. “Clinicians need more tools to help them treat and manage this complex disease. The degree and early onset of skin clearance and itch relief in the Rinvoq phase 3 clinical studies are very encouraging. The outcomes have the potential to advance treatment goals for patients with moderate to severe atopic dermatitis.”
The Marketing Authorization means that Rinvoq is approved in all member states of the European Union, as well as Iceland, Liechtenstein, Norway and Northern Ireland. Rinvoq is already approved for the treatment of moderate to severe atopic dermatitis in Russia, Saudi Arabia, United Arab Emirates, New Zealand and Chile, and is currently under review in the U.S. by the Food and Drug Administration (FDA).
Discovered and developed by AbbVie scientists, Rinvoq is a selective and reversible JAK inhibitor that is being studied in several immune-mediated inflammatory diseases. In human cellular assays, Rinvoq preferentially inhibits signaling by JAK1 or JAK1/3 with functional selectivity over cytokine receptors that signal via pairs of JAK2. Rinvoq 15 mg is also approved by the FDA for adults with moderately to severely active rheumatoid arthritis, and by the European Commission for adults with moderate to severe active rheumatoid arthritis, adults with active psoriatic arthritis (PsA) and adults with active ankylosing spondylitis (AS).