Company: SNY
Filing Date: 2025-02-13
Form Type: 20-F
Source: 0001121404-25-000010
Chunk: 57

Company: Sanofi
Filing Date: 2025-02-13
Form: 20-F
Chunk 57
---
 study showed positive results in children aged one to 11 years with EoE, making this the fifth pediatric pivotal study across three type 2 inflammatory diseases to reinforce the well-established efficacy and safety profile of Dupixent. In January 2024, Dupixent was approved by the FDA for the treatment of adult and pediatric patients aged one year or older, weighting at least 15 kilograms, with EoE. The EoE pediatric indication was approved in the EU in November 2024 Prurigo nodularis (PN) Prurigo nodularis is a chronic, debilitating skin disease with underlying type 2 inflammation and has one of the highest impacts on a patient’s quality of life among inflammatory skin diseases due to the extreme itching it causes. People with PN experience intense, persistent itching, with thick skin lesions (called nodules) that can cover most of the body. The disease is often painful – with burning, stinging and tingling of the skin – and can negatively affect mental health, daily living activities and social interactions. High-potency topical steroids are commonly prescribed but are associated with safety risks if used long-term. The FDA evaluated the Dupixent application for PN under Priority Review on May 31, 2022. On September 29, 2022, the FDA approved Dupixent for the treatment of adult patients with PN. With this approval, Dupixent became the first and only medicine specifically indicated to treat PN in the US. The FDA approval was based on data from two Phase 3 studies evaluating the efficacy and safety of Dupixent in adults with PN. Efficacy in these studies assessed the proportion of subjects with clinically meaningful reduction in itching, clearing of skin, or both. On December 15, 2022, the EC expanded the marketing authorization for Dupixent in the EU to treat adults with moderate-to-severe PN who are candidates for systemic therapy, after the previous positive recommendation on November 11, 2022. The Dupixent PN indication was approved in Japan on June 26, 2023, and in China on September 22, 2023. Chronic spontaneous urticaria (CSU) CSU is a chronic inflammatory skin disease characterized by the sudden onset of hives on the skin and/or swelling deep under the skin. Despite standard-of-care treatment, people with CSU often experience symptoms including a persistent itching or burning sensation, which can be debilitating and significantly impact quality of life. Swelling often occurs on the face,