AbbVie's blockbuster product for atopic dermatitis, Upadacitinib, has been approved for marketing in the EU and Japan

On August 24 and 25, 2021 local time, AbbVie’s blockbuster product RINVOQ (upatinib, an oral and reversible selective JAK inhibitor) was obtained in two important markets, namely the European Union and Japan, respectively. Batch for the treatment of moderate to severe atopic dermatitis adults and adolescent patients 12 years and older who are suitable for systemic treatment. It is reported that upatinib is currently being reviewed by the U.S. Food and Drug Administration (FDA) in the United States. In March of this year, the Center for Drug Evaluation of the National Medical Products Administration of China included Upadacitinib in the list of priority review varieties.

Dr. Alan Irvine, professor of dermatology at Trinity College Dublin and RINVOQ clinical researcher, said: “As a dermatologist who has been researching and treating atopic dermatitis for more than 25 years, I have witnessed the damage this disease has caused to patients’ daily lives. Sexual impact. Clinicians need more means to help patients treat and manage this complex disease. In the phase 3 clinical study of RINVOQ, the extent of skin lesion removal and itching relief and the speed of onset are very encouraging These results have the potential to improve treatment goals for patients with moderate to severe atopic dermatitis."

The EC's approval is based on data support from one of the largest phase 3 registered clinical studies in the field of atopic dermatitis, which included more than 2,500 adults and adolescents with moderate to severe disease. These studies evaluated the effectiveness and safety of RINVOQ monotherapy (Measure Up 1[MU1] and Measure Up 2[MU2]) and combination therapy with topical glucocorticoids (AD UP[AU]) compared to placebo sex. In all 3 studies, the composite primary endpoint was an improvement in the rash severity index by at least 75% from baseline at week 16 (EASI 75) and the validated investigator’s overall assessment of atopic dermatitis (vIGA-AD) The score is 0/1.

The safety profile of RINVOQ is supported by clinical projects for various approved indications (evaluating more than 10,500 patients) and its marketing experience in rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis.