FDA application is based on the positive data from 3 recent phase 3 clinical trials.
AbbVie has submitted regulatory applications for upadacitinib (RINVOQ) as a potential treatment for atopic dermatitis.
The company announced on Oct. 19 they were submitting the applications to the US Food and Drug Administration (FDA), as well as the European Medicines Agency (EMA) to use upadacitinib 15 mg and 30 mg once daily for adults and 15 mg once daily for adolescents with moderate to severe atopic dermatitis.
The applications are based on positive data from a trio of phase 3 studies where the study drug was tested without topical corticosteroids in Measure Up 1 and Measure Up 2, as well as with topical corticosteroids in AD Up.
For all 3 studies, upadacitinib demonstrated significant improvement in skin clearance, as well as a reduction in itch in both adult and adolescent patients with moderate to severe atopic dermatitis when compared to placebo. The study drug met the co-primary endpoints, including at least a 75% improvement in the Eczema Area Severity Index (EASI 75) from baseline and a validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD) score of 0/1 (clear or almost clear) at week 16.
The investigators also found more patients treated with either dose of upadacitinib experienced a clinically meaningful reduction in itch defined as an improvement in the Worst Pruritus Numerical Rating Scale (NRS) of at least 4.
In addition, the safety profile of the study drug was consistent across all 3 studies and no new safety risks was observed.
"While there have been advancements in care, patients with moderate to severe atopic dermatitis continue to experience relentless itch and skin symptoms that can impact their everyday lives," Michael Severino, MD, vice chairman and president, AbbVie, said in a statement. "These submissions are an important step forward in our commitment to providing an additional treatment option for those who struggle with this debilitating and often underappreciated disease."