Sanofi, Regeneron gain 7th Dupixent approval for treating hives

Sanofi and Regeneron have achieved another milestone with their widely acclaimed drug, Dupixent. Recently, the U.S. Food and Drug Administration (FDA) gave its approval for Dupixent to be used in treating chronic spontaneous urticaria (CSU), a skin condition characterized by sudden outbreaks of hives and severe itching. This marks Dupixent's fourth new indication approval in the past 16 months and its seventh overall, underscoring its growing reputation as a versatile and effective medication. The FDA's decision makes Dupixent the first new treatment for CSU in over ten years, providing a new ray of hope for patients affected by this difficult-to-manage condition.

Dupixent's journey to this approval was not without obstacles. Initially, the FDA had rejected the drug as a treatment for CSU in 2023, requesting additional data to support its efficacy. However, armed with more robust clinical results, Sanofi and Regeneron managed to convince the regulators of Dupixent's potential benefits for CSU patients. The drug is now sanctioned for use in individuals aged 12 and older who continue to experience symptoms despite treatment with histamine-1 (H1) antihistamines. With over 300,000 people in the U.S. fitting this criterion, Dupixent's approval could significantly impact many lives.

CSU predominantly affects women aged 30 to 50, and the condition can be both physically and emotionally challenging due to its unpredictable nature. Alyssa Johnsen, M.D., Ph.D., Sanofi's global lead for immunology and oncology development, emphasized the importance of this approval, highlighting that Dupixent provides a new treatment avenue for CSU patients who previously had limited options. By addressing the underlying drivers of the condition, Dupixent has the potential to improve patient outcomes significantly.

The approval follows the results of clinical trials that tested Dupixent's efficacy in CSU patients. The initial phase 3 trial failed to meet its objectives, as Dupixent did not show significant improvement across the primary evaluation criteria. However, the subsequent Liberty-Cupid C trial, which involved 148 CSU patients already receiving standard-of-care antihistamine therapy, met both its primary and secondary objectives. Patients who added Dupixent to their treatment regimen experienced a significant reduction in itch severity and hive appearance compared to those who received a placebo.

In the Liberty-Cupid C study, participants treated with Dupixent saw an 8.6-point improvement in itch severity on a 21-point scale, compared to a 6.1-point improvement in the placebo group. Additionally, the Dupixent group reported a 15.9-point reduction in itch and hive severity on a 42-point scale, as opposed to an 11.2-point reduction among those on placebo. Remarkably, 30% of patients receiving Dupixent achieved a complete response, a noteworthy improvement over the 18% in the placebo group.

Dupixent's approval for CSU adds to its growing list of indications for conditions involving type 2 inflammation. These include atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyps, eosinophilic esophagitis, prurigo nodularis, and chronic obstructive pulmonary disease (COPD). Additionally, Dupixent has already been approved for CSU in other countries such as Japan, Brazil, and the United Arab Emirates, with European regulators currently reviewing the application.

While Dupixent continues to expand its reach, it faces competition from existing treatments like Xolair, which was approved for CSU in 2014 and generated $4.7 billion in sales last year. However, Xolair may soon confront biosimilar competition, prompting Novartis to develop a new CSU treatment, the BTK inhibitor remibrutinib, which has already shown promise in phase 3 trials.