In a letter, the FDA stated that additional efficacy data are required to support an approval for chronic spontaneous urticaria (CSU), according to the manufacturers of dupilumab.
Please confirm that you would like to log out of Medscape. If you log out, you will be required to enter your username and password the next time you visit.says. No safety or manufacturing issues were cited, and an ongoing clinical trial"continues to enroll patients, with results expected in late 2024 that are anticipated to provide the additional efficacy data," the statement adds.
In study B, which evaluated efficacy and safety, the company said results provided"additional supporting data" for the approval application. In a poster presented at the European Academy of Dermatology and Venereology Congress, which was held in September in Berlin, researchers found that patients with CSU who were treated with dupilumab experienced a significant drop in urticaria and an improvement in general and disease-specific health-related quality of life at week 24. Additionally, dupilumab was well tolerated, and safety was consistent with the known safety profile for dupilumab.
In addition to CSU, dupilumab is being studied for treatment of chronic inducible urticaria triggered by cold in an ongoingMarcia Frellick is a freelance journalist based in Chicago. She has previously written for the Chicago Tribune, Science News, and Nurse.com, and was an editor at the Chicago Sun-Times, the Cincinnati Enquirer, and the St. Cloud Times. Follow her on Twitter at
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