Express FDA approves AbbVie's JAK inhibitor for atopic dermatitis

▎WuXi AppTec Content Team Editors Today, the U.
S.
Food and Drug Administration announced the approval of AbbVie’s Rinvoq (upadacitinib) for the expanded indication for the treatment of moderate-to-severe atopic dermatitis in adults or children 12 years of age and older—patients with Failure to respond to previous treatment, and the condition cannot be controlled with other treatments, or other treatments should not be used
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This is another JAK inhibitor approved by the FDA today for the treatment of atopic dermatitis (for another new drug, please refer to the headline report of WuXi AppTec today)
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Upadacitinib is a selective and reversible JAK inhibitor
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In August 2019, it received U.
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FDA approval for the treatment of adults with moderately to severely active rheumatoid arthritis who have an inadequate response to or intolerance to methotrexate
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Today's FDA approval is based on a large Phase 3 development program evaluating 2,500 patients across 3 studies, approximately 52% of whom had previously received systemic atopic dermatitis therapy
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The study showed that upadacitinib (15 mg and 30 mg, oral daily) monotherapy, and combination therapy with topical corticosteroids, met all primary and secondary clinical endpoints after 16 weeks of treatment, and achieved EASI 90 and EASI The proportion of patients with 100 was also significantly higher
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In all three studies, the researchers observed significant improvements in the degree of pruritus in patients with the drug, with effects seen as early as one week after administration
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▲ The specific results of 3 clinical trials (image source: Reference [1]) In terms of safety, the data observed in the treatment group are similar to the safety characteristics previously observed in patients with rheumatoid arthritis
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Other specific adverse reactions associated with atopic dermatitis include eczema herpeticum/Kaposi's varicelliform eruption
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The therapy may also carry potentially serious adverse effects associated with JAK inhibitors, including serious infections, increased risk of death in patients 50 and older with at least one cardiovascular risk factor, cancer and immune system problems, and cardiovascular disease risk and thrombosis
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"Despite available treatments, many patients with moderate-to-severe atopic dermatitis suffer from endless itching that requires scratching," said Emma Guttman-Yassky, professor of dermatology at Mount Sinai School of Medicine.
"In clinical trials, upadacitinib was Demonstrated robust relief in skin and pruritus symptoms, may help patients whose diseases are not adequately controlled, changing their treatment goals
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As an oral tablet with two doses, upadacitinib could also be a tool in a physician's toolbox supplementation, helping them make a significant difference in the lives of patients with moderate to severe atopic dermatitis
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"Reference: [1] US FDA Approves RINVOQ® (upadacitinib) to Treat Adults and Children 12 Years and Older with Refractory, Moderate to Severe Atopic Dermatitis, Retrieved January 14, 2022, from https:// news-releases/us-fda-approves-rinvoq-upadacitinib-to-treat-adults-and-children-12-years-and-older-with-refractory-moderate-to-severe-atopic-dermatitis-301461377.
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The opinions in this article do not represent WuXi AppTec's position, nor do they represent WuXi AppTec's support or opposition to the views in the article
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