For patients struggling with relentless hives and swelling, a new FDA approval brings hope as Dupixent is now authorised to treat chronic spontaneous urticaria in those 12 and older

In a major win for Sanofi and Regeneron, the US Food and Drug Administration (FDA) has approved Dupixent (dupilumab) for the treatment of chronic spontaneous urticaria (CSU) in patients aged 12 years and older. This approval expands the blockbuster drug's use to yet another immune-mediated skin condition, reinforcing its growing dominance in the immunology market.

CSU is a condition marked by persistent hives, itchiness and swelling under the skin, often without a known trigger, and typically continues for six weeks or more. It can significantly impact quality of life and is notoriously difficult to manage, especially in patients who do not respond to standard antihistamines.

The milestone comes after a previous setback in 2023, when the FDA had declined approval due to insufficient efficacy data. According to Sanofi reports, the agency's recent green light is based on robust results from two pivotal Phase 3 trials, Study A and Study C encompassing biologic-naive patients who continued to show symptoms despite antihistamine use. Both trials successfully met their primary and key secondary endpoints, showing that Dupixent, when used alongside antihistamines, significantly reduced itch severity and urticaria activity at 24 weeks compared to placebo.

Additionally, Study B supported the safety profile of Dupixent in patients unresponsive or intolerant to anti-IgE therapy, further strengthening the approval case. Notably, patients treated with Dupixent were more likely to achieve well-controlled disease or even a complete response.

With this latest approval, Dupixent is now cleared for treating CSU, asthma, eczema and chronic lung disease, further broadening its role in addressing immune-related conditions.

According to Sanofi reports, more than 300,000 patients in the US are eligible for Dupixent as a treatment for CSU. In 2023 alone, Sanofi recorded approximately €13 billion ($15 billion) in global sales from Dupixent, underlining the drug’s blockbuster status.

As the need for targeted therapies in immune-related conditions continues to rise, Dupixent’s expanded indication is set to offer a new level of relief for thousands of CSU patients who have limited treatment options.