Sanofi and Regeneron Achieve FDA Approval for Dupixent to Treat Chronic Spontaneous Urticaria
In a significant development for patients suffering from chronic spontaneous urticaria (CSU), Sanofi and Regeneron have received U.S. Food and Drug Administration (FDA) approval for Dupixent, marking its seventh indication. This milestone comes just 18 months after an initial rejection when the FDA requested additional data to support efficacy claims for the skin condition.
Dupixent, a leading treatment for various conditions associated with type 2 inflammation, is on track to generate an impressive $14 billion in sales by its seventh year on the market. The drug’s recent approval as a treatment for CSU makes it the first new medicine to enter this therapeutic arena in over a decade.
Understanding Chronic Spontaneous Urticaria
Chronic spontaneous urticaria is characterized by sudden, unpredictable hives and intense itching. The condition affects approximately 3 million people in the United States, with over 300,000 individuals aged 12 and older being symptomatic despite using histamine-1 (H1) antihistamines. Women aged 30 to 50 are particularly susceptible to this inflammatory skin disease. According to Alyssa Johnsen, M.D., Ph.D., Sanofi’s global lead for immunology and oncology development, “This FDA approval provides a new treatment option to help address the underlying drivers of these severe and recurring signs and symptoms.”
A Journey to Approval
Dupixent’s journey to FDA approval for CSU was not without challenges. Initially, the drug faced setbacks after a phase 3 trial, known as Liberty-Cupid B, involving 108 patients who did not respond adequately to Xolair, a treatment by Novartis and Roche. Despite showing numerical improvements in some evaluation criteria, Dupixent failed to achieve significant symptom relief.
However, the efficacy of Dupixent was convincingly demonstrated in the subsequent Liberty-Cupid C study. This trial involved 148 CSU patients currently on standard-of-care antihistamines, with Dupixent administered as an add-on therapy. Results showed an average reduction of 8.6 points in itch severity (on a scale of 21) for patients receiving Dupixent, compared to a 6.1-point reduction for the placebo group. Similarly, Dupixent-treated patients experienced a 15.9-point reduction in itch and hive severity (on a 42-point scale), while the control group had an 11.2-point improvement. Notably, 30% of patients on Dupixent achieved a complete response after 24 weeks of therapy, compared to 18% in the placebo group.
Dupixent’s Broader Impact
The approval of Dupixent for CSU adds to its list of indications, including atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyps, eosinophilic esophagitis, prurigo nodularis, and chronic obstructive pulmonary disease (COPD). Dupixent has already been approved in Japan, Brazil, and the United Arab Emirates for CSU and is currently undergoing evaluation in Europe.
In contrast, Xolair, which covers similar indications to Dupixent and was approved for CSU in 2014, generated $4.7 billion in sales last year. With the looming threat of biosimilar competition, Novartis is introducing a new CSU treatment known as remibrutinib, a BTK inhibitor that has shown promise in two phase 3 trials.
Conclusion
The FDA’s nod for Dupixent to treat CSU represents a crucial advancement in dermatological treatments, offering a new hope for those suffering from this challenging condition. With a rapidly growing portfolio and positive clinical outcomes, Dupixent is positioned to improve the quality of life for many patients, addressing a significant unmet medical need.
As Sanofi and Regeneron continue to explore Dupixent’s potential across various inflammatory indications, the success of their collaborative efforts underscores the importance of innovative therapies in medicine. The healthcare community and patients alike will be watching closely as they seek further advances in treatment options for chronic conditions associated with type 2 inflammation.