The registration for the biologic dupilumab (Dupixent) has been extended from adults and adolescents with severe, uncontrolled atopic dermatitis to include the treatment of children aged six to eleven years.
The expanded TGA indication allows private prescription of dupilumab for children who have failed to respond to optimally prescribed topical treatments for severe, uncontrolled atopic dermatitis.
Unlike for older age groups, dupilumab is not yet listed on the PBS for treatment of the six to eleven year age group, though the manufacturer Sanofi said it was working with the PBAC, Department of Health and Federal Government to extend the PBS listing to children. The drug, which is given by subcutaneous injection every four weeks has previously been reported to cost around $1,600 for two 300 mg SC doses.
The biologic agent is a monoclonal antibody that inhibits the signalling of the interleukin 4 (IL-4) and interleukin-13 (IL-13) proteins to target the type 2 inflammation that underlies immune system overreaction in atopic dermatitis.
Sydney-based dermatologist, Dr Li-Chuen Wong said the extension of the registration was welcome news for children who experience relentless itch, pain and sleep disruption, which increases their risk of depression, negatively impacts schooling, and impacts the whole family.
“As the first biologic to target the underlying immune dysregulation associated with atopic dermatitis, this therapy represented a paradigm shift in our treatment of adults and adolescents with severe atopic dermatitis, so it is good news that this treatment paradigm is being extended to children,” Dr Wong said in a media statement released by Sanofi.
“Dupixent targets the proteins responsible for immune dysregulation, but it is not an immunosuppressant so it provides an important alternative to oral corticosteroids and immunosuppressants which may have troubling side-effects when used long-term, especially on the developing bodies of children,” Dr Wong said.
“In contrast, Dupixent is generally well-tolerated across all age groups and has a good safety profile in younger patients,” she said.
Approximately 9,000 Australian children are living with severe atopic dermatitis and are more likely to suffer from depression and anxiety than those without the condition.
According to Sanofi, the extended registration was based on evidence from a 16-week trial, involving 367 children with severe atopic dermatitis, which showed significant improvement in signs, symptoms, and quality of life when dupilumab was used with topical steroids compared to placebo.
In the phase 3 study, dupilumab was associated with reduced disease severity, reduced itch and higher rates of cleared skin compared to placebo.
Dupilumab is also registered for treatment of moderate to severe atopic dermatitis in patients aged 12 years and older who are candidates for chronic systemic therapy; add-on maintenance treatment in patients aged 12 years and older with moderate to severe asthma with type 2 inflammation (elevated eosinophils or elevated FeNO); maintenance therapy for oral corticosteroid dependent asthma.; and add-on maintenance treatment in adult patients with inadequately controlled chronic rhinosinusitis with nasal polyposis (CRSwNP).