FDA Approves Dupixent for Chronic Spontaneous Urticaria, Marking Seventh Indication

Sanofi and Regeneron's blockbuster biologic Dupixent has received FDA approval for the treatment of chronic spontaneous urticaria (CSU), becoming the first new targeted therapy for this condition in over a decade. The approval, which comes 18 months after an initial rejection, marks Dupixent's seventh indication in type 2 inflammation-driven diseases.

Overcoming Regulatory Hurdles

The FDA's decision follows a complex development path for Dupixent in CSU. After an initial rejection in October 2023 due to a lack of efficacy data, Sanofi and Regeneron bolstered their case with additional clinical trial results. The LIBERTY-CUPID program, comprising three Phase III studies, provided the necessary evidence to secure approval.

Study C, which enrolled patients with uncontrolled symptoms despite antihistamine treatment, demonstrated that Dupixent reduced itch and urticaria activity scores by nearly 50% compared to placebo. This data, along with results from Study A, which showed similar efficacy, was pivotal in reversing the FDA's earlier decision.

Clinical Impact and Patient Population

The approval covers patients aged 12 and older who remain symptomatic despite antihistamine treatment, a group estimated to include over 300,000 individuals in the United States. CSU, an inflammatory skin disease causing sudden, unpredictable hives and severe itching, affects approximately 3 million people in the country, with the highest incidence among women aged 30 to 50.

Dr. Alyssa Johnsen, Sanofi's global lead for immunology and oncology development, stated, "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."

Market Implications and Competition

Dupixent, which generated nearly $14 billion in sales last year, faces a competitive landscape in the CSU market. Novartis and Roche's Xolair, approved for CSU in 2014, remains a significant player with $4.7 billion in sales last year. However, with Xolair facing upcoming biosimilar competition, the field is evolving.

Novartis is developing remibrutinib, an oral BTK inhibitor that has shown promise in two Phase III trials for CSU. Additionally, companies like Celldex Therapeutics and Jasper Therapeutics are advancing therapies aimed at improving upon the standard of care.

While some analysts view Dupixent's potential in CSU as modest compared to emerging agents, its proven efficacy and established safety profile across multiple indications may contribute to its adoption in this new therapeutic area.