Require additional efficacy data for Dupixent approval for chronic spontaneous urticaria: USFDA to Sanofi
Dupixent is a fully human monoclonal antibody that inhibits the signaling of the IL-4 and IL-13 pathways and is not an immunosuppressant.;
Paris: Sanofi has announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for the supplemental Biologics License Application (sBLA) for Dupixent (dupilumab) in chronic spontaneous urticaria (CSU). CSU is an inflammatory skin condition, which causes sudden and debilitating hives and swelling on the skin.
The CRL states that additional efficacy data are required to support an approval; it did not identify any issues with safety or manufacturing. An ongoing clinical trial (Study C) continues to enroll patients, with results expected in late 2024 that are anticipated to provide the additional efficacy data.
"Sanofi and Regeneron remain committed to working with the FDA to advance the study of Dupixent for patients living with CSU who are inadequately controlled by antihistamines," the release stated.
The potential use of Dupixent in CSU is currently under clinical development, and the safety and efficacy have not been fully evaluated by any regulatory authority.
The clinical trial program, known as LIBERTY-CUPID, includes Studies A, B and C, three Phase 3 randomized, double-blind, placebo-controlled trials evaluating the efficacy and safety of Dupixent in two different patient populations with uncontrolled CSU.
Dupixent is a fully human monoclonal antibody that inhibits the signaling of the IL-4 and IL-13 pathways and is not an immunosuppressant.
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