Research & Development
AbbVie submits regulatory applications to FDA and EMA for RINVOQ to treat atopic dermatitis
20 October 2020 -

Healthcare company AbbVie (NYSE:ABBV) said on Monday that it has filed applications with the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) seeking approval for RINVOQ for the treatment of adults in 15 mg and 30 mg, once daily and adolescents in 15 mg, once daily with moderate to severe atopic dermatitis supported by data from three pivotal Phase 3 studies.

In all three studies, RINVOQ (upadacitinib) demonstrated significant improvement in skin clearance and reduction in itch in adults and adolescents with moderate to severe atopic dermatitis compared to placebo. RINVOQ met the co-primary endpoints of 75% improvement in the Eczema Area Severity Index from baseline and a validated Investigator's Global Assessment for Atopic Dermatitis, said the company.

Atopic dermatitis is reportedly characterized by a cycle of itching and scratching that leads to cracked, scaly, oozing skin, which intensifies with worsening disease severity.

The company stated RINVOQ is a selective and reversible JAK inhibitor that is being studied in several immune-mediated inflammatory diseases. RINVOQ is a prescription medicine used to treat adults with moderate to severe rheumatoid arthritis.

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