AbbVie has secured European approval for 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 approval from the European Commission (EC) 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% 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.
“This is a significant milestone for AbbVie in our pursuit to transform care in atopic dermatitis,” said Michael Severino, 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 Marketing Authorization means that Rinvoq is approved in all member states of the European Union, as well as Iceland, Liechtenstein, Norway and Northern Ireland.
It 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 US by the Food and Drug Administration (FDA).