Dupixent® Approved as First New Targeted CSU Therapy in Over a Decade in U.S.

Regeneron Pharmaceuticals and Sanofi have announced that the U.S. Food and Drug Administration (FDA) has approved Dupixent® (dupilumab) for individuals aged 12 and older who experience chronic spontaneous urticaria (CSU) and remain symptomatic despite antihistamine treatment. This approval is significant as it marks Dupixent as the first targeted therapy for CSU in over a decade, offering hope to over 300,000 patients in the U.S. dealing with symptoms such as severe itching and unpredictable hives, even after standard antihistamine treatments.

Chronic spontaneous urticaria is a persistent inflammatory skin condition driven by type 2 inflammation, resulting in unexpected and intense hives and itching. This disease often remains uncontrolled by traditional H1 antihistamines, leaving many patients with inadequate treatment options. The approval of Dupixent provides a new avenue for these individuals, potentially improving their quality of life by alleviating debilitating symptoms.

The FDA's decision to approve Dupixent for CSU is grounded in the results from two pivotal Phase 3 clinical trials, known as Study A and Study C. These trials, which involved patients aged 12 and older who had not responded adequately to antihistamines, demonstrated that Dupixent significantly reduced the severity of itching and hives compared to a placebo. Additionally, Dupixent increased the likelihood of achieving well-controlled disease or a complete response over 24 weeks. An additional study, Study B, provided further safety data, focusing on patients who were inadequate responders or intolerant to anti-IgE therapy.

Safety assessments from the Phase 3 trials indicated that the adverse events associated with Dupixent were generally consistent with its known safety profile across other approved indications. The most commonly recorded side effect was reactions at the injection site. Alyssa Johnsen, M.D., Ph.D., from Sanofi, expressed optimism that this new treatment will address the underlying causes of CSU symptoms, offering a meaningful option for patients who previously had limited therapeutic alternatives.

Dupixent's approval in the U.S. for CSU adds to its growing list of global approvals, including in countries such as Japan, the United Arab Emirates, and Brazil. Ongoing reviews are being conducted by other regulatory authorities worldwide, including in the European Union. Dupixent is now approved for seven chronic conditions related to type 2 inflammation, which include atopic dermatitis and asthma, conditions that often co-exist with CSU.

The development of Dupixent was achieved through Regeneron's proprietary VelocImmune® technology. This fully human monoclonal antibody targets the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways, key drivers of type 2 inflammation. Importantly, Dupixent is not an immunosuppressant, setting it apart from many other treatments.

The availability of Dupixent for CSU is expected to provide new hope and improved outcomes for patients dealing with this challenging condition, marking a significant advancement in the management of chronic spontaneous urticaria.