Company: SNY
Filing Date: 2025-02-13
Form Type: 20-F
Source: 0001121404-25-000010
Chunk: 94

Company: Sanofi
Filing Date: 2025-02-13
Form: 20-F
Chunk 94
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ihistamines and refractory to omalizumab). c. Dupixent’s pivotal LIBERTY-BP Phase 3 study in bullous pemphigoid (BP) met the primary and all key secondary endpoints evaluating its use in adults with moderate-to-severe disease. Dupixent had previously been granted orphan drug designation by the FDA for this chronic and relapsing disease, characterized by intense itch and blisters, reddening of the skin, and painful chronic lesions. The blisters and rash can form over much of the body and cause the skin to bleed and crust, resulting in patients being more prone to infection and affecting their daily functioning. Results of the LIBERTY-BP study served as the basis for the submission of the sBLA of Dupixent for the treatment of adults with moderate-to-severe BP. d. The LIBERTY-CPUO-CHIC Study A Phase 3 study evaluating Dupixent in adults with uncontrolled and severe chronic pruritus of unknown origin (CPUO) did not achieve statistical significance in its primary itch responder endpoint (despite favorable numerical improvements) but showed nominally significant improvements in all other itch endpoints. The Dupixent Phase 3 study program in CPUO consists of Study A and Study B. Study B is intended to be initiated as a subsequent pivotal study. e. A Regeneron-sponsored Phase 2/3 study evaluating Dupixent in adult and adolescent patients with eosinophilic gastritis with or without eosinophilic duodenitis is ongoing. f. A Phase 3 program to evaluate Dupixent in adults with lichen simplex chronicus was initiated in 2024. g. Finallly, a Phase 2 clinical study is ongoing for the treatment of patients with ulcerative colitis. Kevzara , a monoclonal antibody against the IL-6 receptor developed with Regeneron, is already marketed for the treatment of moderate to severe rheumatoid arthritis and polymyalgia rheumatica. In 2024, the FDA approved Kevzara for the treatment of patients weighing 63 kilograms or greater with active polyarticular juvenile idiopathic arthritis (pJIA), a form of arthritis that impacts multiple joints at a time. The approval in this patient population was supported by evidence from adequate and well-controlled studies and pharmacokinetic data from adults with rheumatoid arthritis as well as a pharmacokinetic, pharmacodynamic, dose finding and safety study in pediatric patients with pJ