Sanofi to present growth opportunities and development strategy for Dupixent (dupilumab) in type 2 inflammatory diseases - Seite 2

Part B of the Phase 3 trial is ongoing, and, if the results are positive, regulatory submissions are expected to be filed by the end of 2022. The U.S. Food and Drug Administration (FDA) has granted orphan drug designation to Dupixent for the treatment of EoE. Currently, no FDA-approved treatments are available for this condition.         

• Chronic Obstructive Pulmonary Disease (COPD) with Evidence of Type 2 Inflammation – Dupixent may benefit COPD patients with evidence of type 2 inflammation. Currently, a Phase 3 study is underway in COPD, with approximately 900 patients enrolled. A second confirmatory study is now being initiated based on a rigorously defined, prespecified futility analysis of data from the ongoing COPD trial. If successful, regulatory submissions would be made in the 2024 timeframe. In the U.S., approximately 300,000 patients with COPD continue to suffer exacerbations despite available treatment options.
   
• Prurigo Nodularis (PN) – PN is a skin disease resulting in intense itching (pruritus) that adversely impacts quality of life, with many patients developing anxiety and depression. Currently, no approved treatments are available for PN, which represents a significant unmet need with approximately 74,000 patients eligible for a biologic in the U.S.           

Currently, two Phase 3 studies are underway testing Dupixent, each enrolling 150 patients with PN. Topline trial results are expected in 2021, which could support regulatory filings at the end of 2021.

    · Chronic Spontaneous Urticaria (CSU) – CSU is a common condition characterized by the recurrent appearance of highly pruritic (itchy) wheals (hives) with or without angioedema. CSU patients experience debilitating hives and pruritus secondary to mast cell and basophil dysregulation. Approximately, 40-50% of patients do not respond to approved treatments including antihistamines and other biologic treatments. Approximately 300,000 patients are eligible for a biologic in the U.S.
             
Earlier this year, a 240 patient registrational study of Dupixent in CSU was initiated, and if the results are positive, regulatory filings would be submitted in 2022.

    · Bullous Pemphigoid (BP) – BP is a rare autoimmune skin disease with type 2 inflammatory features, including pruritic plaques and large fluid-filled blisters. Approximately 27,000 patients are chronically treated with oral corticoid steroids who are potentially eligible for a biologic in the U.S.