Weigh! US FDA today approved the first IL-23 inhibitor for the treatment of psoriasis

Source: Wuxi Medical Co., Ltd July 14, 2017 Janssen biotech, a biotech company owned by Johnson & Johnson, announced today that the US FDA has approved its heavyweight new drug tremfya (guselkumab) for the treatment of moderate to severe plaque psoriasis These adult patients can be used for systemic therapy or phototherapy Tremfya is the first and only approved biological therapy that selectively targets IL-23, which plays a key role in the pathogenesis of plaque psoriasis After receiving the initial dose twice at week 0 and week 4, the patients received subcutaneous injection of tremfya at the dose of 100mg every 8 weeks Guselkumab developed by Janssen biotech is a new psoriasis drug As a monoclonal antibody, it is different from the current standard anti-tumor necrosis factor (TNF) drugs It has a new target for autoimmune inflammatory diseases It can combine and inhibit the body's immune inflammatory medium, interleukin-23 (IL-23) ▲ the molecular mechanism of psoriasis (photo source: Nature Medicine) tremfya was approved by FDA based on a series of large-scale clinical development plans, involving more than 2000 patients in the three-stage voyage 1, voyage 2 and navigate studies These detailed research data have been published in peer-reviewed journals and reported at the 25th European Academy of Dermatology and Venereology Congress and the 2017 American Academy of Dermatology annual meeting Summary as follows: results from voyage 1 and voyage 2 show that tremfya has a significant effect on patients with moderate to severe plaque psoriasis In the clinical study, at the 16th week, at least 7 of 10 patients treated with tremfya achieved at least 90% clear and healthy skin, and more than 80% healthy or almost healthy skin At week 16, tremfya also improved scalp symptoms and other plaque psoriasis symptoms such as itching, pain, tingling, burning and skin tension Tremfya treatment resulted in sustained, healthier and clearer skin At the 28th week, nearly 9 of the 10 tremfya treated patients reached the PASI 90 index, and maintained this response during the 48th week Dr Andrew Greenspan, vice president of medical affairs of Janssen, said: "in the past 15 years, Janssen has focused on finding additional safe and effective treatments for plaque psoriasis With this in mind, we have adopted the priority review voucher strategy for the application process of tremfya in order to provide this novel treatment to patients as soon as possible "