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Yesterday, the FDA awarded Sanofi/Regenerative Dupixent (dupilumab, dupilumab) breakthrough treatment designation for patients aged 12 and older with eosinophilic esophitis (EoE), foreign media reported.
this finding is based on positive results from Phase 3 clinical trial Part A in EoE patients.
as early as 2017, Dupixent was also awarded the title of Orphan Drug for potential EoE treatment.
Dupixent is a human monoclonal antibody that inhibits signaling of leuriocyte mesothrin-4 (IL-4) and leuri cell mesothrin-13 (IL-13) proteins.
previous clinical trials, IL-4 and IL-13 are key drivers of type 2 inflammation and play a major role in asthma, CRSwNP and adesthetic dermatitis (AD).
Currently, the drug has been approved in the United States for the treatment of moderate to severe AD patients 6 years of age and older, while outside the United States, including the European Union and Japan, Dupixent has been approved for the treatment of moderate to severe AD, asthma, and some adult patients with severe CRSwNP.
, NMPA approved the drug for the treatment of moderate to severe AD in adults.
, Dupixent has conducted 50 clinical trials in more than 10,000 patients for a variety of chronic diseases caused by type 2 inflammation.
In addition to the currently approved adaptations, Sanofi and Regenerative Are working together on a wide range of diseases caused by type 2 inflammation or other allergic reactions, including childhood asthma (6-11 years, phase III. clinical), childhood endexual dermatitis (6 months to 5 years, phase III. Clinical), EoE (Phase III. Clinical), Chronic Obstructive Pulmonary Disease (Phase III. Clinical), Herpes-like herpes (Phase III. Clinical), Nodding Itch (Phase III. Clinical), Chronic Spontaneous Urticaria (Phase III. Clinical), Food and Environmental Allergy (Phase II. Clinical).
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