Sanofi/Dupixent's treatment of EoE received FDA breakthrough therapy designation

On September 14, the FDA awarded Sanofi/Regenerative Dupixent (dupilumab, dupilumab) breakthrough treatment designation for the treatment of patients aged 12 years and older with eosinophilic esophitis (EoE).
as early as 2017, Dupixent was also awarded the title of Orphan Drug for potential EoE treatment.
this finding is based on positive results from Phase 3 clinical trial Part A in EoE patients.
the two companies previously reported positive results from a critical Phase 3 trial, Part A, which evaluated EoE patients 12 years of age and older for Dupixent treatment.
the trial was a randomized, double-blind, placebo-controlled trial involving 81 patients, 85 percent of whom had at least one allergic disease, such as allergic rhinitis, food allergies and asthma.
24-week treatment period, patients received 300 mg of Dupixent (42 cases) or placebo (39 cases) per week.
common main endpoints were baseline changes in the Dysphagia Symptom Questionnaire (DSQ) and the proportion of patients who had a peak of 6 eos/hpf in the upper endocys of the esophagus at 24 weeks.
the trial reached two main end points, as well as all the key secondary endpoints.
the 24-week treatment period, symptoms, esoptogram inflammation and abnormal results from endoscopy of the esoptogram were reduced in patients taking 300 mg dupixent per week.
the specific results from baseline to week 24 of treatment were as follows: Symptoms of the disease were measured on the DSQ scale, and on the 0-84 scale, the Dupixent treatment group improved by 21.92 points and the placebo group by 9.60 points.
69 per cent reduction in symptoms of disease in the Dupixent treatment group and a 32 per cent reduction in the placebo group (p-0.0002) to reach a common primary endpoint of the study; In the Dupixent treatment group, 60 percent of patients had an acidophil count that dropped to the normal range, compared with 5 percent in the placebo group, another common primary endpoint of the study;
39 percent for endoscopic abnormalities in the Dupixent treatment group and 0.6 percent for the placebo group (p.0001).
Phase 3 trial Part A also demonstrated that the drug's safety results were consistent with the known safety of its approved adaptations.
the overall adverse events of the drug and placebo were 86% and 82%, respectively, during the 24-week treatment period.
The EoE trial is still ongoing, with more patients joining another trial called Part B, and others continuing to have an extended active treatment period of 28 weeks (i.e. Part C trial) after completing Part A or Part B.
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).
the drug has been approved in the United States for the treatment of moderate to severe AD patients 6 years of age and older who do not have good control over their condition on the basis of the use of dermato prescription therapy (local therapy) or are unable to use local therapy.
In addition, Dupixent has been approved for use with other asthma drugs for moderate to severe eosinophil growth or oral steroid-dependent asthma maintenance in patients aged 12 and older who cannot be controlled with existing asthma medications;
outside the United States, including the European Union and Japan, Dupixent has been approved for treatment for 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 3 clinical), childhood endexual dermatitis (6 months to 5 years, stage 3) Clinical), EoE (Phase 3 Clinical), Chronic Obstructive Pulmonary Disease (Phase 3 Clinical), Large Herpes-like herpes (Phase 3 Clinical), Nodding Itch (Phase 3 Clinical), Chronic Spontaneous Urticaria (Phase 3 Clinical), Food and Environmental Allergy (Phase 2 Clinical).
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