New anti-inflammatory drugs! Sanofi / regenerant dupixent is under priority review in the United States for the treatment of moderate to severe atopic dermatitis in children aged 6-11 years!

January 29, 2020 / BIOON/ --Sanofi and Zaihuan announced recently that the US Food and Drug Administration (FDA) has accepted and will give priority to examining a supplementary biological product license application (SBLA) of the anti-inflammatory drug dupixent (dupilumab): as an additional maintenance therapy, it is used for the treatment of children aged 6-11 who fail to fully control the disease with external prescription therapy or when these therapies are not desirable Atopic dermatitis (AD) FDA has designated the target date of PDUFA as May 26, 2020 In 2016, the FDA awarded dupixent a breakthrough drug qualification for the treatment of severe AD in children aged 6 months to 11 years old with poorly controlled external prescription drugs The SBLA is based on the results of a key dupixent pediatric phase III clinical study (nct03345914) This is a randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of dupixent combined with standard care topical corticosteroids (TCS) in the treatment of children with severe AD (covering an average of nearly 60% of the skin surface) A total of 367 patients with severe AD aged 6-11 years were enrolled in the study Overall, 92% of patients have at least one concurrent disease, such as allergic rhinitis, asthma and food allergy All patients were treated with TCS throughout the study These patients were randomly assigned to three treatment groups for 16 weeks: the first group received 300 mg subcutaneously every 4 weeks (initial dose of 600 mg); the second group received 100 mg or 200 mg subcutaneously every 2 weeks (based on weight adjustment, < 30 kg dose of 100 mg, ≥ 30 kg dose of 200 mg), initial dose of 200 mg or 400 mg; the third group received every 2 weeks Weekly or once every 4 weeks The primary end point was the proportion of patients with a investigator's overall assessment (IGA) score of 0 (clearance) or 1 (near clearance) and a 75% improvement in the eczema severity index (easi-75, a common primary end point outside the United States) within 16 weeks The results showed that the study reached the primary and secondary endpoints Data showed that dupixent combined with TCS significantly improved the overall disease severity, skin clearance, pruritus and health-related quality of life in children with severe AD compared with TCS In addition, the safety data were consistent with those previously recorded in the 12-year-old and older patient population, including a numerically lower skin infection rate compared to placebo The results of 16 weeks treatment included: (1) 33% patients in the first group and 30% patients in the second group achieved IgA score of 0 (clearance) or 1 (almost clearance), while 11% patients in the placebo group (P < 0.0001 and P = 0.0004, respectively) (2) 70% and 67% of the patients in the first group and the second group achieved 75% or higher skin improvement (easi-75), respectively, and 27% in the placebo group (all P < 0.0001) (3) The mean easi scores of the first and second groups were improved by 82% and 78% compared with the baseline, while those of the placebo group were 49% (all P < 0.0001) (4) Dupixent showed significant pruritus relief and improved measures of patient reported outcomes, such as anxiety, depression, and health-related quality of life for parents and family members During the 16 week treatment period, the total incidence of adverse events in the first and second groups was 65%, 67%, and 73% in the placebo group More common adverse events in dupixent treatment included conjunctivitis (7% in the first group, 15% in the second group, and 4% in the placebo group), nasopharyngitis (13% in the first group, 7% in the second group, and 7% in the placebo group), injection site reactions (10% in the first group, 11% in the second group, and 6% in the placebo group) Other pre-defined adverse events included skin infection (6% in the first group, 8% in the second group, 13% in the placebo group), herpes virus infection (2% in the first group, 3% in the second group, and 5% in the placebo group) According to the results, dupixent is the first biological agent to show positive results in this pediatric (6-11 year old) ad population Dupixent is a key driver of type 2 inflammation It is a humanized monoclonal antibody that specifically inhibits the over activation of two key proteins, IL-4 and IL-13 IL-4 / IL-13 are two kinds of inflammatory factors It is believed that IL-4 / IL-13 is the key driver of intrinsic inflammation in allergic diseases and other type 2 inflammatory diseases, including atopic dermatitis, asthma, eosinophilic esophagitis, grass allergy, peanut allergy, etc Dupixent became the world's first biological agent for the treatment of moderate to severe atopic dermatitis at the end of March 2017 Up to now, the drug has been approved by many countries and regions, including the United States, the European Union and Japan In the United States, dupixent is now approved for the treatment of three types of inflammatory diseases caused by type 2: moderate to severe atopic dermatitis (≥ 12-year-old patients), moderate to severe asthma (≥ 12-year-old patients), and chronic rhinosinusitis with nasal polyps (crswnp, adult patients) At present, Sanofi and Zaihuan are also carrying out a wide range of clinical projects to evaluate dupixent's treatment of allergic and other type 2 inflammatory diseases, including: Children's asthma (6-11 years old, phase III), children's atopic dermatitis (6 months to 5 years old, phase II / III), eosinophilic feeding tube inflammation (phase III), chronic obstructive pulmonary disease (phase III), food and environmental allergy (phase II) In addition, a clinical study is planned to evaluate the combination of dupixent and IL-33 targeted monoclonal antibody regn3500 Dupixent is another important product jointly developed by Sanofi and Zaiyuan after PCSK9 inhibitor praluent, which is expected to become a drug that changes the rules of the game At present, dupixent indications are steadily increasing, and evaluatepharma, a well-known pharmaceutical market research organization, has predicted that the global sales of the drug in 2024 may reach 8 billion US dollars Sanofi: FDA accepts for priority review duplex (dupilumab) for children aged 6 to 11 years with model to severe atopic understanding