New drugs for special dermatitis! AbbVie Rinvoq submits new adaptation applications in the U.S. and Europe to treat adult and adolescent patients!

Oct 22, 2020 // -- AbbVie recently announced that it has submitted a new application for Rinvoq (upadacitinib) to the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), a drug Selective, reversible JAK inhibitors for the treatment of adult patients with moderate to severe idiopathic dermatitis (atopic dermatitis, AD) (15mg and 30mg once daily) and adolescent patients (15mg, once daily).
August, the company also submitted new adaptation applications to the FDA and EMA for Rinvoq's treatment of adult patients with active orthopathic spina blinitis (AS).
application for Rinvoq therapy-like dermatitis adaptation, supported by data from 3 key Phase 3 clinical studies.
in Measure Up 1 and Measure Up 2 studies, Rinvoq was not used in a joint application with topical corticosteroid hormone (TCS), and in the AD Up study Rinvoq was used in a joint drug with TCS.
results showed that in all three clinical studies, Rinvoq treatment significantly improved dermatic removal rates and itching levels in adult and adolescent patients with moderate to severe idiopathic dermatitis compared to placebo.
Rinvoq reached a common major endpoint, including treatment with a 16th week eczema area and severity index (EASI) at least 75% improvement over the baseline (EASI 75), and an overall assessment (vIGA AD) score of 0/1 (skin loss removal or near complete removal).
addition, a higher proportion of patients treated with any dose of Rinvoq had a clinically significant reduction in itching symptoms, defined as the most severe itching numerical scale (NRS) ≥4.
Rinvoq's safety was consistent in three key Phase 3 studies of endexual dermatitis.
in these studies, Rinvoq's treatment of admissive dermatitis did not reveal any new safety risks compared to the safety observed in patients treated with rheumatoid arthritis, psoriasis arthritis, and severe spina bifiditis.
special dermatitis (Photo: icresearch.net) special dermatitis (AD) is a common, chronic, recurrent, inflammatory skin disease that manifests itching and scratching in repeated cycles, leading to pain and rupture of the skin.
estimates that as many as 25 percent of adolescents and 10 percent of adults will be affected by AD at some point in their lives.
20%-46% of adult AD patients will have moderate to severe illness.
the symptoms of the disease can cause significant physical, psychological and economic burdens to the patient.
Rinvoq's active drug ingredient is upadacitinib, an oral selective and reversible JAK1 inhibitor discovered and developed by AbbVie and is being developed to treat several immunomedulated inflammatory diseases.
JAK1 is a kinase that plays a key role in the pathophysiology of a variety of inflammatory diseases.
August 2019, Rinvoq received the world's first treatment in the United States for adult patients with moderate to severe active rheumatoid arthritis (RA) who have inadequate or insatiable response to methotrexate (MTX).
December 2019, Rinvoq was approved by the European Union to treat adult patients with moderate to severe RA who do not respond well or are insatiable to one or more disease-modified rheumatoid drugs (DMARD).
in RA, the approved dose for Rinvoq is 15 mg.
Currently, AbbVie is developing Rinvoq to treat a variety of inflammatory diseases, including psoriasis arthritis (PsA), RA, mid-axis spinal arthritis (axSpA), Crohn's disease (CD), adiopathic dermatitis (AD), ulcerative colitis (UC), and cytoarthritis (GCA).
industry is very bullish on Rinvoq's business prospects.
a report by Evaluate Pharma, a pharmaceutical market research organization, predicted that Rinvoq's global sales would reach $2.57 billion by 2024, making it the world's fifth-best-selling anti-rheumatoid drug.
() Origin: AbbVie Submits Regulatory applications to FDA and EMA for RINVOQ? (upadacitinib) in Atopic Dermatitis