Recently, Regeneron and Sanofi announced Dupilumab (brand name:Dupixent) The supplemental Biologics License Application (sBLA) for the treatment of chronic rhinosinusitis with nasal polyps (CRSwNP) in adolescent patients has been approved by the FDA. This means,DupilumabBecame the first drug in the United States targeting 12-17 year oldsAdolescentsTherapy for CRSwNP Patients.This approval is mainly based on two Phase III studies (SINUS-24 and SINUS-52).DupilumabBased on the positive treatment outcomes in adult patients. A total of 724 cases were included in the two studies.Adult patients with CRSwNP were evaluatedThe efficacy and safety of dupilumab (300mg, once every 2 weeks) in these patients. The primary endpoint of the study was at week 24.Change in severity of nasal congestion/nasal obstruction symptoms from baseline and change in Nasal Polyp Score (NPS) from baseline.InIn the SINUS-24 study, compared with placebo,Patients in the Dupilumab groupSignificant improvement in nasal congestion/nasal stuffiness symptoms (score difference of 0.89,p<0·0001), NPS score also significantly decreased (The score difference is 2.06,p<0·0001）。In the SINUS-52 study, compared with placebo, the dupilumab group showed significant improvement in nasal congestion/nasal obstruction symptoms (score difference of 0.87,p<0·0001), the NPS score also significantly decreased (the score difference was 1.80,p<0·0001）。
At the same time,DupilumabHas also reducedAdult patients with CRSwNPThe need for systemic corticosteroid medications or surgery.DupilumabIs a fully human monoclonal antibody against IL-4Rα co-developed by Regeneron and Sanofi. It can inhibit the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways, thereby playing a therapeutic role in inflammatory diseases. In March 2017,DegreePrilYouMonoclonal AntibodyFirst approved for marketing, with the indication ofModerate to severe cases where local prescription preparations cannot adequately control symptoms or are not applicableAdult patients with atopic dermatitis. AdultCRSwNP indication was approved by the FDA in June 2019.CRSwNP is a chronic, recurrent upper airway disease, partly driven by type 2 inflammation. This inflammation obstructs the sinuses and nasal cavity, potentially causing breathing difficulties, nasal congestion and discharge, reduced or lost sense of smell and taste, facial pressure, sleep disturbances, and decreasing the overall quality of life for patients. Many CRSwNP patients also suffer from other type 2 inflammatory diseases, such as asthma.Currently, only three biologics have been approved globally for targeted treatment.CRSwNP, namely omalizumab,Mepolizumab andDegreePrilYouMonoclonal antibody.Copyright © 2024 PHARMCUBE. All Rights Reserved.
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