FDA accepts application for license for complementary biologics for new anti-inflammatory drug Dupixent

, France'sPharmaceutical(http://giant Sanofi and its partner, Regeneron, announced that theof food anddrugs (http://Administration (
FDA(http://) had accepted an application for a license for a supplemental biological product (sBLA) for the new anti-inflammatory drug Dupixent and granted priority reviewthe sBLA sought approval of Dupixent as an additional maintenance therapy for treating adult patients with severe chronic nasal-sinusitis with out-of-control conditions (CRSwNP)About Dupixentthe key driver of Dupixent target type 2 inflammation, a humanized monoclonal antibody that specifically suppresses over-activation signals for two key proteins IL-4 and IL-13IL-4/IL-13 is a two-stage inflammatory factor that is believed to be a key driver of intra-inflammatory inflammation in allergic and other type 2 inflammatory diseases, including asexual dermatitis, asthma, acidophilic esophagitis, grass allergy, peanut allergy, etcDupixent was approved at the end of March 2017 as the world's first biological agent for the treatment of moderate lysing myrapy (AD), and has since been approved for treatment of severe asthma, Sanofi and Regeneration are also conducting an extensive clinical project to evaluate Dupixent's treatment of allergies and other types of inflammation, including: children (6-11 years) of atopic dermatitis (phase III), children (6 months to 5 years) Sexual dermatitis (phase II/III), adolescents (12-17 years) asymptomatic dermatitis (phase III completed), asthma in children (6-11 years) (phase III), eosinophilic esophagealitis (phase II/III), food and environmental allergy (phase II)In addition, the two sides also plan to conduct a clinical study to evaluate the combination of Dupixent and IL-33 target mono-resistance REGN3500 　　The study this sBLA is supported by data from two key placebo-controlled Phase III clinical studies (SINUS-24, SINUS-52) The data were presented at the 2019 annual meeting of the American Society for Allergy, Asthma and Immunology (AAAAI) in San Francisco, U.S., at the end of February These two studies were conducted in adult sons who had previously undergone surgery and/or systemic corticosteroids but had poorly controlled recurrent severe CRSwNP results showed that the study reached all primary and secondary endpoints: when added to the standard nursing therapy corticosteroid nasal spray, Dupixent improved nasal polyps size, nasal congestion, chronic sinusitis, smell and combined asthma prognosis compared to placebo In these severe patients, Dupixent also reduced the need for systemic corticosteroid use and the need for nasal/sinus surgery