AbbVie's Rinvoq cleared in EU for atopic dermatitis

AbbVie announced Tuesday that the European Commission has expanded the label for Rinvoq (upadacitinib) to include treating moderate-to-severe atopic dermatitis in adults and adolescents 12 years and older who are candidates for systemic therapy. The decision, which follows a positive opinion by the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP), makes Rinvoq the first JAK inhibitor authorised in the EU for this patient population.

Company president Michael Severino said "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 approval is supported by data from a Phase III development programme involving more than 2500 adults and adolescents with moderate-to-severe disease. The Measure Up 1 and Measure Up 2 trials evaluated once-daily monotherapy with Rinvoq versus placebo, while the AD Up study tested how the oral drug fared against placebo when both were given with topical corticosteroids. 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, denoting clear or almost clear, at week 16.

Edge over placebo, Dupixent in trials

All primary and secondary endpoints were met, with significantly more patients achieving EASI 75 compared to placebo. Across the Phase III programme, between 60% and 70% of patients given a lower dose of Rinvoq achieved EASI 75. That range rose to between 73% and 80% when the dose was doubled. However, EASI 75 rates were much lower among placebo patients, falling between 13% and 26% across the programme, with the higher figure seen in AD Up, where patients also received topical corticosteroids. Meanwhile, Rinvoq-treated patients were also significantly more likely than placebo to achieve vIGA-AD 0/1 at week 16, as well as clinically meaningful itch reduction.

In December, AbbVie reported that Rinvoq had also met the primary endpoint of the late-stage Heads Up trial, outperforming Sanofi and Regeneron Pharmaceuticals' Dupixent (dupilumab). Results there showed that 71% of patients given Rinvoq achieved EASI 75 at week 16, compared to 61% in the Dupixent arm.

US decision pending

Rinvoq is already approved in the US and EU to treat rheumatoid arthritis in certain patients, while in Europe, it is also cleared for adults with psoriatic arthritis and ankylosing spondylitis. Meanwhile, besides the EU, Rinvoq has regulatory approvals for atopic dermatitis in Russia, Saudi Arabia, United Arab Emirates, New Zealand and Chile, and is currently under review for that indication by the FDA.

Last month, AbbVie said the US regulator had missed its review deadline on the company's Rinvoq application in atopic dermatitis, having also previously delayed the action date on filings for the drug in psoriatic arthritis and ankylosing spondylitis. The agency has so far postponed decisions for several JAK inhibitors as it conducts a safety review across the drug class (see ViewPoints: FDA continues to hold JAKs after class).