AbbVie Submits Regulatory Applications to FDA and EMA for RINVOQ® (upadacitinib) in Moderate-to-Severe Atopic Dermatitis
Oct 23, 2020 00:51
CST Updated
00:51
AbbVie
Innovative Drug Developer
October 22, 2020 /BioonBIOON/ -- AbbVie recently announced that it has submitted applications for new indications of Rinvoq (upadacitinib), a selective, reversible JAK inhibitor, to the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). The drug is intended for the treatment of adult patients (15 mg and 30 mg, once daily) and adolescent patients (15 mg, once daily) with moderate-to-severe atopic dermatitis (AD). In August this year, the company also submitted applications toFDASubmitted a new indication application to the EMA for Rinvoq in the treatment of adult patients with active ankylosing spondylitis (AS).
Application for the atopic dermatitis indication of Rinvoq, supported by data from three pivotal Phase 3 clinical studies. In the Measure Up 1 and Measure Up 2 studies, Rinvoq was not used in combination with topical corticosteroids (TCS), whereas in the AD Up study, Rinvoq was administered in combination with TCS.
The results demonstrated that, across all three clinical studies, treatment with Rinvoq led to significant improvements in both skin clearance and pruritus severity among adult and adolescent patients with moderate-to-severe atopic dermatitis, compared with placebo. Rinvoq met the co-primary endpoints, including achieving at least a 75% improvement from baseline in the Eczema Area and Severity Index (EASI 75) at Week 16, and attaining a score of 0/1 (clear or almost clear skin) on the validated Investigator’s Global Assessment for Atopic Dermatitis (vIGA-AD). Additionally, a higher proportion of patients receiving any dose of Rinvoq experienced a clinically meaningful reduction in pruritus, defined as a baseline Worst Pruritus Numerical Rating Scale (NRS) score ≥4.
In three pivotal Phase 3 studies of atopic dermatitis, the safety profile of Rinvoq was consistent. Across these studies, no new safety risks were identified with Rinvoq treatment for atopic dermatitis compared to the safety observed in patients with rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis treated with Rinvoq.
Atopic Dermatitis (Image source: icresearch.net)
Atopic Dermatitis (AD) is a common, chronic, relapsing, inflammatory skin disease characterized by a recurrent cycle of itching and scratching, leading to painful, cracked skin. It is estimated that up to 25% of adolescents and 10% of adults are affected by AD at some point in their lives. Between 20% and 46% of adult patients with AD experience moderate-to-severe disease. The symptoms of this condition impose significant physical, psychological, and economic burdens on patients.
The active pharmaceutical ingredient of Rinvoq is upadacitinib, an oral, selective, and reversible JAK1 inhibitor discovered and developed by AbbVie, which is being developed for the treatment of several immune-mediated inflammatory diseases. JAK1 is a kinase that plays a key role in the pathophysiology of various inflammatory diseases.
In August 2019, Rinvoq received its first global approval in the United States for the treatment of moderate to severe active rheumatoid arthritis in patients who have had an inadequate response or intolerance to methotrexate (MTX).Rheumatoid Arthritis(RA) adult patients. In December 2019, Rinvoq received EU approval for the treatment of adult patients with moderate to severe RA who have had an inadequate response or intolerance to one or more disease-modifying antirheumatic drugs (DMARDs). The approved dose of Rinvoq for RA is 15 mg.
Currently, AbbVie is developing Rinvoq for the treatment of multiple inflammatory diseases, including psoriatic arthritis (PsA), rheumatoid arthritis (RA), axial spondyloarthritis (axSpA), Crohn’s disease (CD), atopic dermatitis (AD), ulcerative colitis (UC), and giant cell arteritis (GCA).
The industry holds a very optimistic view of Rinvoq’s commercial prospects. A previously released report by the pharmaceutical market research firm EvaluatePharma predicted that Rinvoq’s global sales would reach $2.57 billion in 2024, making it the fifth best-selling antirheumatic drug worldwide. (Bioon.com)