Sanofi/Regeneron report positive late-stage results for Dupixent in chronic spontaneous urticaria

Sanofi and Regeneron have announced promising results for their drug Dupixent (dupilumab) in the treatment of chronic spontaneous urticaria (CSU). According to late-stage trial data, Dupixent significantly alleviates itchiness and hives in affected patients.

The companies plan to submit detailed results from the confirmatory trial to the US Food and Drug Administration (FDA) before the year ends. This submission follows a request from the FDA for additional data on Dupixent's effectiveness in treating CSU.

The trial, part of the phase 3 LIBERTY-CUPID program, included over 150 CSU patients aged six and older. Participants were randomly assigned to receive either Dupixent or a placebo, in addition to standard antihistamine treatment. Those included in the study continued to experience symptoms despite antihistamine use and had not previously been treated with Xolair (omalizumab) from Novartis and Genentech.

Results showed an 8.64-point reduction in itch severity from baseline in the Dupixent group, compared to a 6.10-point reduction for placebo at 24 weeks. Moreover, Dupixent demonstrated superior efficacy in reducing overall urticaria activity, including both itchiness and hive severity. The Dupixent group experienced a 15.86-point reduction from baseline, compared to an 11.21-point reduction in the placebo group at the same 24-week mark.

Additionally, 30% of patients treated with Dupixent reported a complete absence of urticaria symptoms, compared to 18% in the placebo group. The safety profile of Dupixent was consistent with its known effects in other approved dermatological conditions.

Chronic spontaneous urticaria is an inflammatory skin condition affecting around 40 million people globally. It is characterized by red, raised, itchy, and sometimes painful hives or wheals that persist for six weeks or longer. While H1 antihistamines are commonly used to treat CSU, many patients find the condition remains uncontrolled.

Dupixent is a fully human monoclonal antibody that targets the interleukin-4 and interleukin-13 pathways. These pathways are significant drivers of type 2 inflammation, which is involved in multiple diseases, including CSU. The development program for Dupixent has highlighted its potential in addressing this central aspect of inflammation.

Dietmar Berger, Sanofi’s chief medical officer and global head of development, commented on the findings: “The positive pivotal data from this study reinforces the potential of Dupixent to offer a new treatment option for the many people suffering from CSU who do not respond to standard-of-care antihistamines. With clinically meaningful reductions in itch and hives for patients receiving Dupixent, we look forward to sharing this data with the FDA to bring Dupixent to patients with CSU in the US as soon as possible.”

The promising results from this trial indicate that Dupixent could become a significant new option for those suffering from chronic urticaria, providing relief where traditional treatments have failed. Sanofi and Regeneron continue to move forward in bringing this innovative therapy to market, aiming to improve the quality of life for millions of CSU patients worldwide.

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