FDA Issues Complete Response Letter for Dupilumab sBLA in Chronic Spontaneous Urticaria, Requesting Additional Efficacy Data

On October 20, Regeneron and Sanofi announced receipt of a Complete Response Letter (CRL) from the U.S. FDA regarding the supplemental Biologics License Application (sBLA) for Dupixent (dupilumab) in the treatment of Chronic Spontaneous Urticaria (CSU). The CRL indicated that additional efficacy data is needed to support approval. Regeneron stated that an ongoing clinical trial (Study C) will continue to enroll patients, with results expected by the end of 2024, which will provide additional efficacy data.

The clinical trial program, code-named LIBERTY-CUPID, includes three Phase III randomized, double-blind, placebo-controlled trials: Study A, Study B, and Study C. It aims to evaluate the efficacy and safety of dupilumab in two different populations of uncontrolled CSU patients.

Study A evaluated the efficacy and safety of dupilumab as an add-on therapy to standard antihistamines in 138 patients aged 6 years and older with CSU, compared with antihistamines alone. These patients continued to have symptoms despite the use of antihistamines and had not previously received omalizumab treatment.

Sanofi announced positive results from Study A on July 29, 2021. The trial met its primary endpoint and all key secondary endpoints at 24 weeks. In biologic-naïve patients, dupilumab in combination with standard-of-care antihistamines significantly reduced itch and hives symptoms compared to antihistamines alone (placebo).

Study B evaluated the efficacy and safety of dupilumab in 108 CSU patients aged 12 to 80 years. These patients continued to experience symptoms despite standard treatment and were intolerant or had an inadequate response to omalizumab.

The ongoing Study C is evaluating the therapeutic effects of dupilumab in the same population as Study A.

The NextPharma database of PharmaCube shows that the indications approved by drug regulatory authorities for dupilumab now include: atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyps, prurigo nodularis, and eosinophilic esophagitis.

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