Sanofi, Regeneron win FDA nod for Dupixent in chronic hives

The Food and Drug Administration on Friday approved a new use for Sanofi and Regeneron’s top-selling immune disease drug Dupixent, clearing the medicine to treat a chronic skin condition that causes hives.

The agency OK’d Dupixent for chronic spontaneous urticaria, an inflammatory skin disease that causes hives to form on the body and leads to severe itching, burning or swelling. Dupixent is specifically available for people 12 years of age or older whose symptoms persist despite antihistamine treatment. In a statement, Regeneron estimated more than 300,000 people in the U.S. fit that description.

Urticaria describes a group of hive-forming skin conditions that in recent years have become an active area of drug research. They can crop up either on their own or be induced by environmental factors, such as cold or warm temperatures, and last for weeks or even years at a time.

While people can receive antihistamines or the biologic Xolair, many don’t respond. And even if they do, relief can take weeks. Several drugmakers, including Sanofi and Regeneron, Celldex Therapeutics, Jasper Therapeutics and Novartis, are advancing therapies they claim can improve upon standard care.

Dupixent is the first of this new group to reach market, even after setbacks prolonged its development path. The drug missed the main goal of one of its key studies in 2022. The FDA rejected the companies’ initial application a year later and requested more efficacy data.

Sanofi and Regeneron provided those results in 2024 via a trial called Liberty-Cupid Study C, which enrolled patients who had uncontrolled symptoms and were taking antihistamines. They reported that patients who added Dupixent to their regimen experienced an almost 50% reduction in itch and urticaria activity scores compared to those given a placebo. Those data were the basis for the FDA’s approval Friday.

“Dupixent is the first new targeted treatment for chronic spontaneous urticaria, or CSU, in over ten years, with pivotal trials demonstrating its ability to help patients significantly reduce the hallmark symptoms of intense itch and unpredictable hives associated with this disease,” said Regeneron Chief Scientific Officer, George Yancopoulos, in the company’s statement.

The clearance gives Dupixent, which generated nearly $14 billion in sales last year, seven approved uses. Yet some analysts are skeptical of Dupixent’s commercial potential in urticaria. In a research note last year, analysts at Cantor Fitzgerald said they viewed Dupixent’s results in urticaria as “underwhelming” compared to the data generated so far by Celldex. In March, the investment bank Jefferies, after speaking with dermatologists, said the drug “seems a non factor” compared to other emerging agents for the condition.

Dupixent is already approved for chronic urticaria in Japan, Brazil and the United Arab Emirates. It’s currently under regulatory review elsewhere, including in the EU.

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