FDA Approves Sanofi and Regeneron's Dupixent for Chronic Hives

The U.S. Food and Drug Administration has granted approval for a novel application of the popular drug Dupixent, developed by Sanofi and Regeneron, to address a persistent and challenging skin condition known as chronic spontaneous urticaria (CSU). This condition is characterized by the emergence of hives on the skin, resulting in severe itching, burning, and swelling. Dupixent is now authorized for use in individuals aged 12 and above whose symptoms remain uncontrolled, even after treatment with antihistamines. Regeneron estimates that this new approval could potentially benefit more than 300,000 patients across the United States.

Urticaria encompasses a range of skin disorders that result in hive formation, an area that has garnered increased attention in drug research in recent years. These skin conditions can arise independently or be triggered by environmental factors like temperature variations, lasting anywhere from several weeks to years. Although antihistamines and the biologic drug Xolair are treatment options, not all patients respond to them, and relief may take weeks to manifest. In response to this unmet need, several pharmaceutical companies, including Sanofi and Regeneron, Celldex Therapeutics, Jasper Therapeutics, and Novartis, are actively developing therapies that could potentially offer improvements over existing treatments.

Dupixent stands out as the first drug from this new wave of treatments to successfully reach the market, overcoming several developmental hurdles along the way. The drug's journey faced setbacks, notably in 2022 when it failed to meet the primary endpoint in a critical study. Consequently, in the following year, the FDA rejected the initial application by Sanofi and Regeneron, requesting additional efficacy data. The companies responded by presenting new findings in 2024 from a trial named Liberty-Cupid Study C. This study involved patients with persistent symptoms who were already on antihistamines. The results were promising, showing that patients who incorporated Dupixent into their treatment regimen experienced nearly a 50% reduction in itching and urticaria activity compared to those receiving a placebo. This data ultimately led to the FDA's approval.

This approval marks Dupixent as the first targeted treatment for chronic spontaneous urticaria in over a decade. According to Regeneron's Chief Scientific Officer, George Yancopoulos, the pivotal trials have demonstrated the drug's capacity to significantly alleviate the intense itching and unpredictable hives that are hallmarks of this condition.

Currently, Dupixent boasts seven approved uses and generated nearly $14 billion in sales last year alone. However, some industry analysts harbor reservations about its commercial success in the urticaria market. For instance, a research note from Cantor Fitzgerald expressed that Dupixent's results in this area appeared less impressive compared to those achieved by Celldex. Additionally, Jefferies, after consulting with dermatologists, suggested that Dupixent might face stiff competition from emerging agents targeting the same condition.

In addition to the recent U.S. approval, Dupixent is already authorized for treating chronic urticaria in countries such as Japan, Brazil, and the United Arab Emirates. The drug is also under regulatory review in other regions, including the European Union, where it may soon become available to a broader patient population.