Sanofi announces that the U.S. Food and Drug Administration (FDA) has approved Dupixent (dupilumab) for adult patients with bullous pemphigoid (BP), a rare and serious autoimmune skin disorder. This is the first and only targeted therapy to be available for this patient population in the United States.
Bullous pemphigoid is a chronic autoimmune condition marked by the appearance of large blisters filled with fluid on the skin. The disease can be severely itchy and painful and, in extreme cases, can result in widespread blistering, skin erosions, and extreme disability. It is estimated to occur in about 27,000 adults in the U.S., many of whom have their disease not controlled well with systemic corticosteroids.
People affected by bullous pemphigoid endure unrelenting itch and painful blisters that can damage the skin. Until now, these primarily elderly patients have had limited therapeutic options available, with potential side effects that have often added to their burden. The approval of Dupixent for bullous pemphigoid brings a novel treatment approach to patients and their caregivers, and we are grateful for the tireless efforts of the scientific community who helped us reach this critical milestone.
Patrick Dunn
The FDA approval of Dupixent for the treatment of BP is informed by results from the Phase 2/3 ADEPT trial. In the ADEPT trial, Dupixent showed a substantial increase in sustained remission of disease and decreased itch and oral corticosteroid use over placebo in adult patients with moderate-to-severe BP.
Some of the ADEPT study findings at 36 weeks
- Sustained Disease Remission: 18.3% of Dupixent-treated patients sustained disease remission, compared with 6.1% of the placebo group
- Reduction in Itch: Clinically meaningful itch reduction was seen in 38.3% of Dupixent-treated patients, versus 10.5% of the placebo group.
Until now, treating bullous pemphigoid was very challenging for elderly patients struggling with the debilitating impact of blisters and lesions, and potentially co-morbid conditions. By addressing two central drivers of the underlying type 2 inflammation that contributes to bullous pemphigoid, Dupixent is the first targeted medicine to allow patients the potential to achieve sustained remission and reduce itch. This approval in the US is important for the thousands of patients living with bullous pemphigoid, and we look forward to working with regulators around the world to bring this innovative medicine to more patients in need.
Alyssa Johnsen, MD, PhD
Dupixent is a human monoclonal antibody and is administered as a subcutaneous injection. It does not act as an immunosuppressant. Dupixent inhibits the IL-4 and IL-13 pathways’ signaling it is are thought to be the driving forces of the inflammation in bullous pemphigoid.
The most frequent adverse events that occurred in patients treated with Dupixent in the study were arthralgia (joint pain), conjunctivitis, blurred vision, herpes viral infections, and keratitis.
Dupixent has also been approved for numerous other uses, such as atopic dermatitis, asthma, and chronic rhinosinusitis with nasal polyps, and has won regulatory approval in more than 60 countries. The medication is jointly being developed by Sanofi and Regeneron to a global collaboration agreement.
Last Modified:
Graduated from the University of Kerala with B.Sc. Botany and Biotechnology. Attained Post-Graduation in Biotechnology from the Kerala University of Fisheries and Ocean Science (KUFOS) with the third rank. Conducted various seminars and attended major Science conferences. Done 6 months of internship in ICMR – National Institute of Nutrition, Hyderabad. 5 years of tutoring experience.
