New drugs for special dermatitis! Sanofi Dupixent ® (Dabito®) is recommended by the European Union for the treatment of children aged 6-11 years, listed in China for the treatment of adults!

October 17, 2020 // -- Sanofi and Regeneron have jointly announced that the European Medicines Agency (EMA) Commission on Human Pharmaceutical Products (CHMP) has released An active review recommended approval of the expansion of Dupixent (Chinese product names: Dabito, generic name: dupilumab, dupilumab, dupilumab) for the treatment of children aged 6-11 with moderate to severe endemic dermatitis (AD) suitable for system therapy.
CHMP opinion is the final step in the marketing authorization process before obtaining approval from the European Commission (EC).
, CHMP's comments will now be submitted to the EC for review, which usually takes CHMP's advice and makes a final review decision within 2 months.
June, Dupixent received FDA approval to expand the population for children of moderate to severe AD in the same age group (6-11 years old).
it's worth noting that Dupixent is the first and only biological drug approved in the U.S. for ≥6-year-olds and in the European Union for uncontrolled moderate to severe AD patients ≥12 years of age.
in China, Dupixent was approved by the State Drug Administration in June to treat moderate to severe AD adult patients.
Dabito® is the world's first and only approved treatment of adult moderate to severe specific dermatitis targeted biological agents, to fill the domestic clinical unsuperfected needs, can quickly, significantly and continuously improve the degree of skin damage and itching symptoms in patients with specific dermatitis.
the drug regulatory reform, Dabito was approved ® china two years in advance, providing new treatment options for Chinese patients.
dermatitis (atopic dermatitis, AD) is a refroutable, recurrent, inflammatory skin disease with recurrent severe itching and rash as the main clinical manifestations, patients often combined with allergic rhinitis, asthma and other endexual diseases.
most patients have symptoms of pain and discomfort caused by skin cracking, colic and seepage, which, if not effectively controlled, can affect the emotional and psychological state of the patient, leading to anxiety and depression and loneliness.
patients have said that 12 hours of unstopable intense itching at night the most difficult, can only keep scratching, with pain over itching, a normal sleep is a luxury.
Dupixent is an all-human monoclonal antibody that inhibits signaling from IL-4 and IL-13, and is not an immunosuppressant.
data from the Dupixent clinical trial show that IL-4/IL-13 is a key driver of type 2 inflammation and plays a key role in endexual dermatitis, asthma, chronic nasal-sinusitis associated with nasal psalmology (CRSwNP).
170,000 of the three approved adaptations worldwide received Dupixent treatment.
specialty dermatitis (Photo: icresearch.net) The positive advice of the FDA for the treatment of children aged 6-11 and CHMP in the European Union is based on the results of a key Dupixent Paediatrics Phase III clinical study (NCT03345914).
This is a randomized, double-blind, placebo-controlled study that assessed the efficacy and safety of Dupixent's combined standard care topical corticosteroid (TCS) treatment for severe AD in children (covering nearly 60% of skin surfaces on average).
367 patients in the study group who had severe AD patients aged 6-11 who could not be adequately controlled by local drugs.
, 92 percent of patients suffer from at least one common disease at the same time, such as allergic rhinitis, asthma, and food allergies.
all patients were treated with TCS throughout the study.
these patients were randomly assigned to three treatment groups for a period of 16 weeks: the first group received Dupixent injections every 4 weeks 300 mg (initial dose 600 mg) and the second group received Dupixent injections every 2 weeks 100 mg or 2 00 mg (based on weight adjustment, the dose of <30 kg is ≥ 100 mg and the dose of 30 kg is 200 mg), the initial dose is 200 mg or 400 mg, respectively;
main endpoint is the proportion of patients who within 16 weeks achieved a researcher's overall assessment (IGA) score of 0 (cleared) or 1 (almost cleared) and an improvement in the eczema severity index by 75% (EASI-75, a common primary endpoint outside the United States).
results show that the study reached the main and secondary end points.
data show that in severe AD children, Dupixent combined TCS significantly improved overall disease severity, skin removal, itching, and health-related quality of life compared to TCS.
addition, the safety data were consistent with previous safety data recorded in patient groups 12 years and older, including a lower numerically low rate of skin infections compared to placebos.
16 weeks of treatment results included: (1) 33% of patients in the first and 30% of patients with skin damage with an IGA score of 0 (removal) or 1 (almost cleared), and a placebo group of 11% (p<0.0001 and p.0004, respectively.
(2) 70%, 67% of patients in the first and second groups had skin improvement (EASY-75) of 75% or higher, respectively, and 27% of the placebo group (average p<0.0001).
(3) the average EASI scores of the first and second groups improved by 82%, 78% compared to the baseline, and the placebo group was 49% (average p<0.0001).
(4) Dupixent showed significant itching relief and improved the measurement of patient reporting results such as anxiety, depression, and health-related quality of life for parents and family members.
16 weeks of treatment, the overall risk of adverse events in the first and second groups was 65%, 67%, and 73% in the placebo group.
The more common adverse events of Dupixent treatment included conjunctivitis (7 percent in the first group, 15 percent in the second group, 4 percent in the placebo group), nasopharyngitis (13 percent in the first group, 7 percent in the second group, 7 percent in the placebo group), and injection site reactions (10 percent in the first group, 11 percent in the second group, and 6 percent in the placebo group).
other pre-designated adverse events included skin infections (6 per cent in the first group, 8 per cent in the second group, 13 per cent in the placebo group), and herpes virus infections (2 per cent in the first group, 3 per cent in the second group, and 5 per cent in the placebo group).
Based on the results, Dupixent is the first biologic agent to show positive results in this pediatric (6-11 years old) AD population.
a key driver of Dupixent's targeted type 2 inflammation, the drug is an all-human monoclonal antibody that specifically suppresses overactivation signals of two key proteins, IL-4 and IL-13.
IL-4/IL-13 are two inflammatory factors believed to be key drivers of intracellular inflammation in allergic and other type 2 inflammatory diseases, including endexual dermatitis, asthma, acidophilic esophitis, grass allergy, peanut allergy, etc.
Dupixent became the world's first biological agent to treat moderate to severe specialty dermatitis at the end of March 2017.
, the drug has been approved by many countries and regions, including the United States, the European Union and Japan.
In the U.S., Dupixent is now approved to treat three diseases caused by type 2 inflammation: moderate to severe endexual dermatitis (≥6 years of age), moderate to severe asthma (≥12 years of age), and chronic nasal sinusitis (CRSwNP, adult patients).
, Sanofi and Regeneratives are also conducting an extensive clinical project to assess Dupixent's treatment of diseases caused by allergies and other type 2 inflammations, including: childhood asthma (6-11 years, stage III), childhood endexual dermatitis (6 months to 5 months) Age, Phase II/III), eosinophilic esophagealitis (Stage III), Chronic Obstructive Pulmonary Disease (Stage III), Herpes-like herpes (Phase III), Nodding Itch (Phase III), Chronic Spontaneous Urticaria (Phase III), Food and Environmental Allergy (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.
is now steadily increasing, with Evaluate Pharma, a leading pharmaceutical market research organization, predicting that global sales of the drug will reach $8 billion by 2024.
() Original source: European advisory group backs expanded use of Regeneron/Sanofi's Dupixent<!--/ewebeditor:page->