Innovative drug for eosinophilic esophitis! FDA Grants Sanofi/Regenerative Dupixent Breakthrough Drug Qualification: Phase III Clinical Efficacy Significant!

!-- Webeditor: page title -- Sanofi and partner Regeneron recently jointly announced that the U.S. Food and Drug Administration (FDA) has Awarded the breakthrough drug qualification (BTD) for the new anti-inflammatory drug Dupixent (Chinese commodity name: Dabito, generic name: Dupilumab) for the treatment of patients with 12-year-old eosinophilic esophitis (EoE).
BTD based on the positive results of a key Phase III trial A evaluating Dupixent's treatment of EoE patients.
in 2017, the FDA also granted Dupixent the status of orphan drug (ODD) for the treatment of EoE.
currently, there is no FDA-approved drug to treat EoE.
EoE is a chronic and aggressive type 2 inflammatory disease that damages the esokaido and prevents it from working properly.
over time, excessive type 2 inflammation can lead to esophageal scarring and stenosis, making swallowing difficult.
if left untreated, EoE can affect the patient's ability to eat and cause food to get stuck after swallowing (food plugs), leading to medical first aid.
the United States alone, about 160,000 EoE patients are receiving various unapproved therapies or dietary adjustments, of which about 50,000 have failed.
BTD is a new drug review channel created by the FDA in 2012 to accelerate the development and review of new drugs used to treat serious or life-threatening diseases, and there is preliminary clinical evidence that the drug has significantly improved one or more clinically significant endpoints compared to existing drugs.
access to BTD drugs, and closer guidance, including from senior FDA officials, in the development process to ensure that new treatment options are available to patients in the shortest possible time.
, Sanofi and Regeneration announced that the Key III trial had reached two common major endpoints and all key secondary endpoints at the same time.
the study, Dupixent was the first and only biologic agent to show positive and clinically significant results in Phase III clinical trials in patients with EoE in the 12-year-old age group.
part B of this ongoing Phase III trial is evaluating an additional dosing option for Dupixent, and patients continue to under extended active treatment period (Part C) for 28 weeks after completing Part A or Part B.
the trial, almost half of the patients had surgery such as dilation of the esotheria, and almost three-quarters had been treated with corticosteroids.
-phase III trial of eosinophilic esophagealitis (Photo: frontiersin.org) is a randomized, double-blind, placebo-controlled trial that is evaluating the efficacy and safety of Dupixent's treatment of EoE adolescents and adult patients.
part A of the trial included 81 EoE patients over the age of 12, who were determined by histology and patient reporting results.
study, patients were randomly assigned to receive a weekly subsuplisive dose of Dupixent (n)or a placebo (n=39) for 24 weeks.
Common main endpoints are: treatment of the 24th week of dysphagia symptom questionnaire (DSQ, a patient-reported dysphagia measurement tool) relative to baseline changes, esophagus endophilic cell count peak of 6 eos/hpf (eos/hpf, esophagus inflammation measurement tool).
A patients, the baseline DSQ score was 34 and the average baseline peak level of eos/hpf was 89 eos/hpf.
results showed that from baseline to week 24 of treatment: (1) 69% reduction in symptoms of the disease in the Dupixent group, 32% reduction in the placebo group (p-0.0002), and measurement of disease symptoms by the DSQ scale, which was a common major endpoint of the study: on the 0-84 scale, the Dupixent treatment group improved by 21.92 points and the placebo group improved by 9.60 points.
(2) 60 percent of patients in the Dupixent treatment group had an acidophil count that dropped to a normal range and a placebo group of 5 percent, another common primary endpoint of the study.
(3) the Dupixent group had a 39 percent decrease in endoscopic abnormalities and a 0.6 percent decrease in the placebo group, as measured by the endoscopic reference score (EoE-EREFS), which reduced the Dupixent group by 3.2 points and the placebo group by 0.3 points (p.0001).
tests have shown that Dupixent's security results are similar to the known safety profiles in approved indications.
24 weeks of treatment, Dupixent and placebo had an overall adverse event rate of 86 percent and 82 percent, respectively.
more common adverse events in Dupixent therapy included injection site reactions (15 in the Dupixent group, 12 in the placebo group) and upper respiratory tract infections (11 in the Dupixent group and 6 in the placebo group).
one patient in the Dupixent group stopped taking the drug because of joint pain.
Dupixent, launched at the end of March 2017, has been approved to treat three diseases caused by type 2 inflammation: moderate to severe endexual dermatitis (in patients aged 6 years), moderate to severe asthma (in patients aged 12 years), and chronic nasal sinusitis (CRSwNP, adult patients).
Dupixent is an all-human monoclonal antibody that inhibits signaling of lecytolein-4 (IL-4) and lebinocyte mesotonin-13 (IL-13).
data from the Dupixent clinical trial show that IL-4 and IL-13 are key drivers of type 2 inflammation and play a key role in asthma, CRSwNP and endexual dermatitis.
more than 170,000 patients received Dupixent treatment for all approved adaptations worldwide.
, in June, Dupixent was approved by the State Drug Administration (NMPA) to treat moderate to severe endexual dermatitis (AD) in adults.
Dabito is the world's first and only approved target biologic agent for the treatment of severe specific dermatitis in adults, filling the unsuperfected needs of domestic clinics and rapidly, significantly and continuously improving the degree of dermatation and itching in patients with specific dermatitis.
the drug regulatory reform, Dabito was approved in China two years ahead of schedule, providing Chinese patients with new treatment options.
!--/ewebeditor:page--!--ewebeditor:page title"--Currently, Sanofi and Regeneratives are also conducting an extensive clinical project to evaluate Dupixent's treatment of diseases caused by allergies and other type 2 inflammations, including: Childhood Asthma (6-11) Age, Phase III), Children's Endexual Dermatitis (6 months to 5 years, Phase III), eosinophilic esophagealitis (Phase III), Chronic Obstructive Pulmonary Disease (Phase III), Herpes-like herpes (Phase III), nodding itch (Phase III), chronic spontaneous urticaria (Phase III), food and environmental allergies (Phase II).
Dupixent is another important product developed by Sanofi in partnership with regeneratives following the PCSK9 inhibitor class fat-lowering drug Praluent, and is expected to be a game-changing drug.
, Dupixent's adaptive disorder is steadily increasing, with drug market research agency Evaluate Pharma predicting that global sales of the drug will reach $8 billion by 2024.
origin of the original article: FDA Grants Dupixent® (dupilumab) File Therapy Designation for Eosinophilic Esophagitis !--/ewebeditor:page--