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CHMP recommends approval of Rinvoq for the treatment of atopic dermatitis.- AbbVie.

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Published:27th Jun 2021
AbbVie has announced the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending the approval of Rinvoq (upadacitinib), an oral, selective and reversible JAK inhibitor, for the expanded use in adults (15 mg or 30 mg, once daily) and adolescents 12 years and older (15 mg, once daily) with moderate to severe atopic dermatitis who are candidates for systemic therapy.

Rinvoq is being studied in several immune-mediated inflammatory diseases. The CHMP positive opinion was supported by data from the global Phase III program evaluating more than 2,500 patients with moderate to severe atopic dermatitis across three global pivotal studies: Measure Up 1, Measure Up 2 and AD Up. Across the three studies, both doses of Rinvoq met all primary and secondary endpoints, demonstrating rapid and significant improvement in skin clearance and reduction in itch compared to placebo at week 16 and other time points (p<0.001) in patients with moderate to severe atopic dermatitis. the most commonly reported adverse events in patients treated with rinvoq were acne, nasopharyngitis and upper respiratory tract infections.></0.001)>

Condition: Atopic Dermatitis (Eczema)
Type: drug

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