Express's first topical JAK inhibitor was approved by the FDA to treat atopic dermatitis

▎Incyte, editor of WuXi AppTec's content team, announced today that the US FDA has approved Opzelura (ruxolitinib) cream for short-term and non-continuous long-term treatment of patients with mild to moderate atopic dermatitis (AD) over 12 years old
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These patients have not been adequately controlled after receiving other prescribed topical medications and have no symptoms of immunocompromised function
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The press release states that Opzelura is the first JAK inhibitor external preparation approved by the FDA
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The US FDA's approval is based on two randomized, double-blind, vehicle-controlled Phase 3 clinical trials involving more than 1,200 adolescent and adult patients with mild to moderate AD
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The results of the study showed that, compared with excipients, the proportion of patients who received different doses of Rucotinib cream after receiving treatment for 8 weeks, the proportion of patients who reached the primary endpoint was significantly better than that of the control group
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▲The primary endpoint results of Lucotinib cream in two phase 3 clinical trials (picture source: reference [2]) Atopic dermatitis is a serious chronic and recurrent skin disease
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The main symptoms are itching, dry skin, and inflammation, which can appear on any part of the body
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The symptoms of moderate to severe atopic dermatitis are severe itching, causing visible damage to the skin
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Like other chronic inflammatory diseases, atopic dermatitis is mediated by the immune system and is related to the complex interaction between immune cells and inflammatory cytokines
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Rucotinib cream is a proprietary external formulation of JAK1/JAK2 selective inhibitor Rucotinib
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JAKs belong to the family of cytoplasmic tyrosine kinases, and their function is to transduce signals mediated by cytokines (such as interferon)
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It can regulate the activity of inflammatory factors related to the pathology of atopic dermatitis, and may directly regulate pruritus
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▲The association between atopic dermatitis and JAK signaling pathway (picture source: reference [2]) Incyte CEO Hervé Hoppenot said: "Opzelura's approval is an important advancement in AD treatment, and we are very pleased to provide A new type of topical treatment option that targets a pathway that is believed to be the source of inflammation
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At Incyte, we are committed to changing the treatment of immune-mediated skin diseases
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We look forward to bringing Opzelura to the patient population and continue to explore it Potential in other challenging skin diseases
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"Reference: [1] Incyte Announces US FDA Approval of Opzelura™ (ruxolitinib) Cream, a Topical JAK Inhibitor, for the Treatment of Atopic Dermatitis (AD).
Retrieved September 21, 2021, from https:// com/news/home/20210921006072/en[2] Ruxolitinib Cream: Phase 3 Data in Atopic Dermatitis.
Retrieved February 19, 2021, from https://s21.
q4cdn.
com/114423841/files/doc_presentations/corporate/TRuE_AD_IR_webcast_April_6_2020_vFinal.
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