"The FDA has signed off on Sanofi and Regeneron’s megablockbuster Dupixent to treat patients with chronic spontaneous urticaria. It is the fourth new indication approval for Dupixent in the last 16 months and seventh overall. (Sanofi)
On its way to generating sales of $14 billion in just its seventh full year on the market, Sanofi and Regeneron’s Dupixent has experienced few setbacks. One came in 2023, however, when the FDA rejected it as a treatment for chronic spontaneous urticaria (CSU), asking for more data.
Eighteen months later—and backed by more conclusive results—the companies have convinced the U.S. regulator to sign off on Dupixent for the difficult-to-treat skin condition. With the nod, Dupixent becomes the first new medicine for CSU in more than a decade.
The approval clears Dupixent to be used by those age 12 and older who remain symptomatic despite using histamine-1 (H1) antihistamines. It’s a population of more than 300,000 among the roughly 3 million in the U.S. who have CSU, The incidence of the inflammatory skin disease is highest among women between the ages of 30 and 50. CSU causes sudden, unpredictable hives and a severe itch.
“This FDA approval provides a new treatment option to help address the underlying drivers of these severe and recurring signs and symptoms. Dupixent has the potential to improve outcomes for CSU patients who previously had limited treatment options,” Alyssa Johnsen, M.D., Ph.D., Sanofi’s global lead for immunology and oncology development, said in a statement.
Dupixent was first rejected for CSU after the failure of a phase 3 trial that enrolled 108 patients who did not have success with the only other treatment approved in the indication, Novartis and Roche’s Xolair. In the Liberty-Cupid B study, Dupixent failed to significantly improve symptoms, though numerical improvements were evident in each of the main evaluation criteria.The next trial of Dupixent in the indication, Liberty-Cupid C, achieved its primary and secondary objectives. In the study, which included 148 CSU patients who were already receiving standard-of-care (SOC) antihistamine therapy, adding Dupixent provided a reduction of 8.6 points in itch severity (on a scale of 21) compared to a 6.1-point reduction for patients on placebo plus SOC.
The Dupixent group also saw a 15.9-point reduction in itch and hive severity (on a 42-point scale) versus an 11.2-point reduction for the control group. Additionally, 30% of Dupixent-treated patients experienced a complete response, compared with 18% of those on placebo. The measurements were taken after 24 weeks of therapy.
The trial confirmed results from the successful Liberty-Cupid A study, which also tested Dupixent plus SOC antihistamines against antihistamines alone in 136 patients with moderate-to-severe CSU.CSU is the seventh disease with underlying type 2 inflammation in which Dupixent is approved. The others are atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyps, eosinophilic esophagitis, prurigo nodularis and chronic obstructive pulmonary disease (COPD).
Dupixent has been approved as a treatment for CSU in Japan, Brazil and the United Arab Emirates, and is under review for the indication in Europe."