AbbVie announces that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued its positive opinion for upadacitinib (Rinvoq *) – selective and reversible oral JAK inhibitor – for the treatment of adults (15 mg or 30 mg, once daily) and adolescents from 12 years of age (15 mg, once daily) with moderate to severe candidates for systemic therapy. Upadacitinib is also undergoing clinical development in other immune-mediated inflammatory diseases.
“The inflammation and itching, typical of atopic dermatitis, can have a disruptive impact on the quality of life of those suffering from this chronic inflammatory skin disease, to the point of influencing their choices and lifestyle. ” declares Annalisa Iezzi, Medical Director, AbbVie Italy. “We welcome the positive opinion of the CHMP, since – he underlines – it recognizes the potential of upadacitinib as an additional treatment option for patients with moderate to severe atopic dermatitis. This regulatory milestone confirms our commitment to fill the unmet needs of patients suffering from immune-mediated inflammatory diseases “.
The positive opinion of the CHMP – AbbVie reports in a note – is supported by clinical data from the phase 3 development program which evaluated over 2,500 patients with moderate to severe atopic dermatitis in three clinical studies: Measure Up 1, Measure Up 2 is AD Up. Across the three studies, both Rinvoq strengths met all primary and secondary endpoints, demonstrating rapid and significant improvement in skin clearance and reduction in pruritus compared to placebo at week 16 in patients with moderate to severe atopic dermatitis. The most commonly reported adverse events in treated patients were acne, nasopharyngitis, upper respiratory tract infections, headache, increased creatine phosphokinase (CPK) and oral herpes.
“It is a drug with a remarkable rapidity of action – explains Giampiero Girolomoni, full professor of Dermatology and Director of the Dermatological Clinic, University of Verona – on both itching and skin lesions. With oral upadacitinib, relief from itching occurs within a few days of starting treatment. Efficacy with upadacitinib appears to be very consistent in ensuring resolution of atopic dermatitis in treated subjects. The positive opinion of the CHMP brings us closer to having at our disposal a new and promising therapeutic option capable of ensuring optimal results in achieving clinical remission. Upadacitinib is a candidate to be an innovative treatment, capable of partially or completely modifying the course of atopic dermatitis through a new immune-modulation mechanism. “
The positive opinion of the CHMP – recalls the company note – constitutes a scientific recommendation for the granting of the marketing authorization by the European Commission which will issue its final decision valid in all Member States of the European Union, as well as in Iceland, Liechtenstein, Norway and Northern Ireland. If approved, this will be the fourth indication for upadacitinib, which will be the first JAK inhibitor approved in Europe for the treatment of moderate to severe atopic dermatitis in both adults and adolescents aged 12 years and older.