Monday, July 15, 2024

Sanofi and Regeneron Offer Latest Update on Dupixent® sBLA for Chronic Spontaneous Urticaria

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Sanofi and Regeneron have provided an update regarding Dupixent® (dupilumab) in the context of its supplemental Biologics License Application (sBLA) for the treatment of chronic spontaneous urticaria (CSU), an inflammatory skin condition characterized by sudden and severe hives and skin swelling. The U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for this sBLA, stating the need for additional efficacy data to support its approval. Notably, the CRL did not raise concerns about safety or manufacturing.

To address this requirement, an ongoing clinical trial (referred to as Study C) is currently enrolling patients, and it is anticipated that results from this trial will be available in late 2024. These results are expected to provide the necessary additional efficacy data. Sanofi and Regeneron remain dedicated to collaborating with the FDA to advance the study of Dupixent, specifically for patients with CSU who do not experience sufficient relief from antihistamines.

It’s important to note that the potential use of Dupixent in treating CSU is still in the clinical development stage, and its safety and efficacy have not undergone full evaluation by any regulatory authority.

The clinical trial program for CSU, known as LIBERTY-CUPID, consists of three Phase 3 randomized, double-blind, placebo-controlled trials: Studies A, B, and C. These trials aim to assess the effectiveness and safety of Dupixent in two distinct patient groups with uncontrolled CSU. Study A examined Dupixent as an add-on therapy to standard H1 antihistamines in patients aged six and older who remained symptomatic despite antihistamine use. Study B evaluated Dupixent in patients aged 12 to 80 who remained symptomatic despite standard-of-care treatment. Study C is an ongoing trial investigating Dupixent in the same population as Study A.

Dupixent is a fully human monoclonal antibody that inhibits IL-4 and IL-13 pathways without causing immunosuppression. It has demonstrated clinical benefits and reduced type 2 inflammation in Phase 3 trials, highlighting the significance of IL-4 and IL-13 in driving type 2 inflammation, which is pivotal in various related diseases. These conditions include approved indications for Dupixent, such as atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis (CRSwNP), prurigo nodularis, and eosinophilic esophagitis (EoE).

Dupixent has received regulatory approvals in multiple countries worldwide for various indications in different age groups. It is approved for these indications in more than 60 countries and has been prescribed to over 750,000 patients globally.

The development of Dupilumab is a joint effort between Sanofi and Regeneron. While the currently approved indications are well-established, these companies are also exploring the potential of dupilumab in treating other diseases influenced by type 2 inflammation or allergic processes in Phase 3 clinical trials, which include pediatric EoE, chronic pruritus of unknown origin, chronic obstructive pulmonary disease with evidence of type 2 inflammation, and bullous pemphigoid. It’s important to note that the safety and efficacy of dupilumab in these conditions have not yet been fully evaluated by regulatory authorities.

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