Sanofi and Regeneron present data to support Dupixent for treating hives after FDA rejection

Sanofi and Regeneron have shared promising new data from a phase 3 trial that could lead to FDA approval of their medication, Dupixent, for the treatment of chronic spontaneous urticaria (CSU). This comes nearly a year after the U.S. regulator initially rejected their bid for approval in October of the previous year.

The LIBERTY-CUPID C study, pivotal for Dupixent's approval, successfully met its primary and secondary objectives. Conducted on 151 individuals, both children and adults, the trial evaluated patients already on background antihistamine therapy. Those in the Dupixent group experienced an average reduction of 8.6 points in itch severity on a 21-point scale, compared to a 6.1-point reduction in the control group who received a placebo in addition to standard-of-care (SOC) antihistamines. Additionally, Dupixent-treated patients showed a 15.9-point reduction in itch and hive severity on a 42-point scale, whereas the control group registered an 11.2-point reduction. These measurements were taken after 24 weeks of therapy. Moreover, 30% of patients treated with Dupixent reported a complete response, in contrast to 18% of those on placebo.

Sanofi's Chief Medical Officer, Dietmar Berger, M.D., Ph.D., highlighted the trial's success, stating that the data underscores Dupixent's potential as a new treatment option for those suffering from CSU, particularly those who do not respond to standard antihistamines. Berger mentioned that the data would be submitted to the FDA in hopes of making Dupixent available to CSU patients as soon as possible. The companies plan to file their regulatory resubmission by the end of this year. Earlier in the year, Japan approved Dupixent for CSU.

This trial validates findings from the LIBERTY-CUPID A study, which also showed positive results for Dupixent in combination with SOC antihistamines. However, the LIBERTY-CUPID B trial did not meet its primary endpoints, failing to significantly reduce symptoms in patients who did not respond to the only currently approved CSU treatment, Novartis and Roche’s Xolair. Despite the trial's early termination due to futility, Dupixent did show numerical improvements in key evaluation criteria, including itch severity. This partial success was not enough to secure FDA approval initially, leading to a request for more efficacy data.

CSU affects over 300,000 people in the U.S. who do not find relief with antihistamines alone. Dupixent, a monoclonal antibody, has been on the market for seven years and is already approved for multiple conditions, including atopic dermatitis, asthma, rhinosinusitis, eosinophilic esophagitis, and prurigo nodularis. The FDA is also reviewing Dupixent for chronic obstructive pulmonary disease (COPD). If approved for CSU, Dupixent would be the first new treatment for the condition in over a decade.

Dupixent's sales have surged by 33% to $11.6 billion in 2023, and more than 1 million patients have been treated with the drug. Xolair, which has been approved for CSU since 2014 and shares several indications with Dupixent, generated $4 billion in sales last year. With Xolair facing potential biosimilar competition, Novartis is preparing to introduce a new CSU treatment. The company has shared favorable phase 3 trial results for its oral BTK inhibitor, remibrutinib, and anticipates submitting it for approval next year.

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