FRANCE – Regeneron Pharmaceuticals, Inc. and Sanofi have announced in a joint that the FDA has approved Dupixent (dupilumab) as an add-on maintenance treatment for patients aged 6 to 11 years with moderate-to-severe asthma characterized by high levels of eosinophils or with oral corticosteroid-dependent asthma.
Dupixent has been shown to reduce severe asthma attacks and improve lung function in children aged 6 to 11 years. It was approved in 2017 for the treatment of moderate-to-severe atopic dermatitis.
The versatile injectable monoclonal antibody drug reduces severe asthma attacks and improves lung function.
Asthma is a common, chronic disease that affects approximately 6 million children under the age of 18 in the United States.
According to the CDC, one in every six children with asthma visits the emergency department each year. Asthma in children can impair airway development, reduce lung function, and make people more susceptible to infections.
Despite standard-of-care inhaled corticosteroids and bronchodilators, these children may continue to have serious symptoms such as coughing, wheezing, and difficulty breathing.
According to one study published in Springer: “The Economic Burden of Pediatric Asthma in the United States: Literature Review of Current Evidence,” the total direct costs of pediatric asthma in 2013 were US$5.92 billion.
This review of the literature showed that an average annual costs per child ranged from US$3,076 to US$13,612, with pharmacy, inpatient, and outpatient costs being the major contributors to healthcare costs.
Monoclonal antibody therapies have become increasingly important in the treatment of asthma exacerbations.
Genentech’s Xolair (omalizumab) was the first monoclonal antibody approved for pediatric asthma treatment in 2003.
However, researchers discovered no strong evidence that Xolair treatment modifies asthma evolution, and they say more research in children is needed.
Dupixent, developed by Regeneron Pharmaceuticals and Sanofi, has also been shown to reduce severe asthma attacks and improve lung function in children aged 6 to 11 years.
Dupixent’s mode of action is that it blocks the signaling pathways of interleukin-4 (IL-4) and interleukin-13 (IL-13).
IL-4, and IL-13 are important mediators of inflammation in atopic dermatitis, asthma, and chronic rhinosinusitis with nasal polyposis.
The FDA approval is based on data from a phase 3 trial in which Dupixent was combined with standard-of-care asthma therapy in children with uncontrolled moderate-to-severe asthma.
Patients with high levels of eosinophils who received Dupixent (100 mg or 200 mg every two weeks) in addition to standard-of-care experienced a 65 percent average reduction in severe asthma attacks over a year when compared to placebo.
At 24 weeks, patients had better asthma control, with 81 percent reporting a clinically meaningful improvement in disease symptoms compared to 64 percent of placebo patients.
Furthermore, improved lung function was observed as early as two weeks and lasted for up to 52 weeks. Patients taking Dupixent improved their lung function by 5.32 percentage points after 12 weeks when compared to placebo.
Dupixent is currently under regulatory review in the European Union and other health authorities around the world for children aged 6 to 11 years with moderate-to-severe asthma.
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