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Dupixent: Significantly improves lung function for children with severe asthma
Dupixent: Significantly improves lung function for children with severe asthma. Asthma in children not only brings damage to the body, but also brings great inconvenience to life and schoolwork.
Recently, the U.S. FDA announced that it has accepted the supplementary biologics license application (sBLA) for the IL-4/IL-13 inhibitor duplizumab (trade name: Dabitol) as an uncontrolled patient aged 6 to 11 Additional treatment for children with moderate to severe asthma. It is expected to make an approval response on October 21 this year.
In a randomized phase 3 trial, Duplizumab is the only biological agent that improves lung function in children aged 6-11 years, and is expected to become the best treatment option for such children.
▌Asthma recurs, what should I do with my child’s schoolwork?
Bronchial asthma (asthma) is a chronic inflammatory disease of the airways. The clinical manifestations are recurrent wheezing, shortness of breath, chest tightness, and cough, which often attack or worsen at night and/or in the early morning.
In the United States, about 75,000 children between the ages of 6 and 11 suffer from uncontrolled moderate to severe asthma. Asthma attacks repeatedly, airway inflammation continues to increase, and eventually irreversible structural changes of the trachea may occur, which affects lung function. This can place a heavy burden on children and their families.
At present, the standard of treatment for children with moderate to severe asthma is inhaled corticosteroids and bronchodilators, but these children still experience cough, wheezing, and difficulty breathing. There may also be a risk of severe, life-threatening asthma attacks, leading to hospitalizations and emergency room visits.
Moreover, if children need to use systemic corticosteroids due to the onset of the disease, long-term use of these hormonal drugs will bring significant risks.
Uncontrolled moderate-to-severe asthma can also damage lung function and interfere with daily activities, such as sleeping, going to school, and exercise. It will have a greater impact on children’s body, study and life, and there is an urgent need for a drug with a long-lasting effect.
In recent years, the anti-IgE monoclonal antibodies omalizumab, duplizumab and other new targeted therapies have long-lasting efficacy and safety, which have brought new treatment hope to patients with severe asthma.
▌IL-4/IL-13 inhibitor: Duplizumab
Duplizumab is a fully human monoclonal antibody that specifically inhibits the signaling pathways of interleukin 4 (IL-4) and interleukin 13 (IL-13).
IL-4 and IL-13 are the key and main drivers of type 2 inflammation, and play a major role in asthma, chronic rhinosinusitis with nasal polyps (CRSwNP), atopic dermatitis and eosinophilic esophagitis.
In March 2017, Duplizumab was approved by the U.S. FDA for use in adult patients with moderate to severe atopic dermatitis who are unable to adequately control the condition of external prescription drugs or are not suitable for the treatment of these drugs.
This is the first targeted biological drug for the treatment of moderate to severe atopic dermatitis in adults.
Up to now, Duplizumab has been approved to treat 3 types of inflammation-related diseases: moderate to severe atopic dermatitis (patients ≥ 6 years old), moderate to severe asthma (patients ≥ 12 years old), and nose Chronic rhinosinusitis of polyps (CRSwNP, adult patients).
Among all approved indications worldwide, more than 170,000 patients have been treated with Duplizumab.
In June last year, Duplizumab was approved by the National Food and Drug Administration for the treatment of moderate to severe atopic dermatitis (AD) in adults.
It is the world’s first and only targeted biological agent approved for the treatment of moderate to severe atopic dermatitis in adults, which can significantly and continuously improve the degree of skin lesions and itching symptoms of patients with atopic dermatitis.
▌Significantly improve lung function and dispel childhood shadows of children!
This sBLA received positive data from key Phase 3 clinical trials.
In children with moderate to severe asthma from 6 to 11 years old, Duplizumab significantly reduced the number of severe asthma attacks within 2 weeks, and can quickly improve lung function and slow down the patient’s lung function decline.
At present, there are several clinical trials of Duplizumab in progress, mainly for the treatment of various diseases caused by type 2 inflammation or other allergies.
Moderate to severe asthma brings greater mental stress and life impact to children and their families. It is hoped that the drug will be approved as soon as possible to help children delay the decline of lung function and better control asthma.
(source:internet, reference only)