New medicine for children with atopic dermatitis (AD)!

Dupixent's first targeted biologic drug approved for the treatment of atopic dermatitis has been marketed in China for the treatment of adult patients

Infant atopic dermatitis (picture source: atopicdermatitis.

August 30, 2021/Bio Valley BIOON/ --Sanofi and Regeneron have recently jointly announced the evaluation of the targeted biological agent Dupixent (Chinese trade name: Dabituo, common name: dupilumab, The pivotal phase 3 LIBERTY AD PRESCHOOL trial of Duplizumab in the treatment of children with moderate to severe atopic dermatitis (AD) from 6 months to 5 years of age met the primary and all secondary endpoints

It is worth mentioning that Dupixent is the first biological agent to show positive results in this young population, and it is still the only approved biological agent among patients 6 years and older with uncontrolled moderate to severe atopic dermatitis.

These data further confirm the effectiveness and safety of Dupixent in patients of other age groups, including the lower rate of skin infections in the Dupixent group compared with the placebo group

The detailed data of the trial will be announced at a future medical conference and will be submitted to regulatory agencies

Dr.

George D.

LIBERTY AD PRESCHOOL is a two-part phase 2/3 trial

The pre-specified primary analysis showed that at 16 weeks, 28% of patients in the Dupixent group achieved complete or almost complete removal of skin lesions (IGA 0/1.

EASI improved by an average of 70% in the Dupixent group from baseline and 20% in the placebo group (p≤0.

The trial showed safety results similar to the known safety of Dupixent in the treatment of atopic dermatitis

Dupixent mechanism of action (picture source: dupixenthcp.

Atopic dermatitis (AD) is a chronic type 2 inflammatory disease, and 85-90% of patients are younger than 5 years old

Dupixent was developed by Sanofi and Regeneron.

Dupixent targets the key drivers of type 2 inflammation.

Dupixent was launched at the end of March 2017 and has been approved to treat 3 types of diseases caused by type 2 inflammation: moderate to severe atopic dermatitis (patients ≥ 6 years old), moderate to severe asthma (patients ≥ 12 years old), Chronic rhinosinusitis with nasal polyps (CRSwNP, adult patients)
.
Up to now, Dupixent has been approved for one or more indications in more than 60 countries around the world, treating more than 300,000 patients
.

In China, in June 2020, Dupixent was approved by the National Medical Products Administration (NMPA) for the treatment of moderate to severe atopic dermatitis (AD) in adults
.
Darbitux is the world's first and only targeted biological agent approved for the treatment of moderate to severe atopic dermatitis in adults.
The degree of damage and symptoms of itching
.
Thanks to the promotion of the drug regulatory reform, Dabituo was approved in China two years in advance, providing Chinese patients with new treatment options
.

So far, Dupixent has conducted research in 60 clinical trials involving more than 10,000 patients with various chronic diseases, part of which is caused by type 2 inflammation
.
Currently, Sanofi and Regeneron are carrying out an extensive clinical project to evaluate Dupixent in the treatment of diseases caused by type 2 inflammation or other allergic processes, including: childhood asthma (6-11 years old, stage 3), with type 2 inflammation Evidence of chronic obstructive pulmonary disease (stage 3), eosinophilic esophagitis (stage 3), bullous pemphigoid (stage 3), prurigo nodosa (stage 3), chronic spontaneous urticaria (stage 3) , Chronic induced cold urticaria (stage 3), chronic sinusitis without nasal polyps (stage 3), allergic fungal sinusitis (stage 3), allergic bronchopulmonary aspergillus (stage 3), peanut allergy ( Phase 2)
.
(Bioon.
com)

Original source: Dupixent® (dupilumab) pivotal trial meets all primary and secondary endpoints becoming first biologic medicine to significantly reduce signs and symptoms of moderate-to-severe atopic dermatitis in children as young as 6 months