Sanofi’s Dupixent Receives FDA Priority Review for the Treatment of Bullous Pemphigoid

Sanofi’s Dupixent Receives FDA Priority Review for the Treatment of Bullous Pemphigoid

(IN BRIEF) Sanofi’s Dupixent has been granted FDA priority review for the treatment of bullous pemphigoid (BP), a chronic skin disease. If approved, Dupixent would be the first targeted medicine for BP in the U.S., with the FDA’s decision expected by June 20, 2025. The submission is supported by clinical data showing significant improvements in sustained disease remission.

(PRESS RELEASE) PARIS, 18-Feb-2025 — /EuropaWire/ — The U.S. Food and Drug Administration (FDA) has accepted the supplemental biologics license application (sBLA) for Sanofi’s Dupixent (dupilumab) for priority review as a potential treatment for adults suffering from bullous pemphigoid (BP). If approved, Dupixent would become the first and only targeted therapy for BP in the United States. The FDA’s decision is expected by June 20, 2025.

This application is supported by promising data from a pivotal trial evaluating Dupixent’s safety and efficacy in 106 adults with moderate-to-severe BP. The trial demonstrated that patients treated with Dupixent were five times more likely to achieve sustained disease remission compared to those on a placebo. Sustained disease remission was defined as complete clinical remission with the successful tapering of oral corticosteroids (OCS) by week 16, followed by at least 20 weeks of Dupixent treatment without relapse or the need for rescue therapy over a 36-week period.

Additionally, Dupixent was shown to significantly reduce disease severity, alleviate itching, and decrease reliance on OCS treatment compared to placebo.

However, patients receiving Dupixent reported certain adverse events more frequently than those on placebo. These included peripheral edema, arthralgia, back pain, blurred vision, hypertension, asthma, conjunctivitis, constipation, upper respiratory tract infection, limb injury, and insomnia.

Bullous pemphigoid is a chronic and relapsing skin condition typically affecting older adults, marked by intense itching, painful blisters, and red, inflamed skin. As the condition progresses, the skin can become so damaged that it bleeds and crusts, increasing the risk of infections and severely impacting patients’ quality of life. It is estimated that around 27,000 adults in the U.S. suffer from BP that remains uncontrolled by systemic corticosteroids.

Priority review is granted by the FDA to therapies that have the potential to offer significant advancements in the treatment or management of serious conditions. Dupixent was previously granted orphan drug designation by the FDA for BP, a status designated for medicines intended to treat rare diseases affecting fewer than 200,000 people in the U.S.

While Dupixent’s safety and efficacy for BP are still undergoing clinical evaluation, the application represents a significant step toward offering a targeted treatment option for patients with this debilitating condition.

About Regeneron
Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents, develops and commercializes life-transforming medicines for people with serious diseases. Founded and led by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to numerous approved treatments and product candidates in development, most of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurological diseases, hematologic conditions, infectious diseases, and rare diseases.

Regeneron pushes the boundaries of scientific discovery and accelerates drug development using our proprietary technologies, such as VelociSuite®, which produces optimized fully human antibodies and new classes of bispecific antibodies. We are shaping the next frontier of medicine with data-powered insights from the Regeneron Genetics Center® and pioneering genetic medicine platforms, enabling us to identify innovative targets and complementary approaches to potentially treat or cure diseases.

For more information, please visit www.Regeneron.com or follow Regeneron on LinkedIn, Instagram, Facebook or X.

About Sanofi
We are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve people’s lives. Our team, across the world, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions.

Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY

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SOURCE: Sanofi