The US Food and Drug Administration (FDA) has accepted for priority review the supplemental biologics license application (sBLA) filed by Regeneron Pharmaceuticals and Sanofi for their jointly developed Dupixent (dupilumab).

The license application seeks approval of Dupixent as an add-on maintenance treatment of atopic dermatitis in children aged between six and 11 years, whose disease is not being controlled using topical prescription therapies. The regulatory body is expected to take a decision on Dupixent by 26 May 2020.

According to Regeneron, many young children suffering from atopic dermatitis will experience uncontrolled, persistent symptoms, regardless of standard-of-care therapy.

The symptoms in children include intense, persistent itching, skin lesions and skin dryness, cracking, redness or darkness, crusting and oozing. In addition to the physical symptoms, the disease would affect the health-related quality of life for children, and causes a burden on their families.

Dupixent is used for atopic dermatitis asthma and chronic rhinosinusitis with nasal polyposis

Dupixent is a fully human monoclonal antibody that inhibits the signalling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) proteins, which are drivers of type 2 inflammation that plays a key role in atopic dermatitis, asthma and chronic rhinosinusitis with nasal polyposis (CRSwNP).

Regeneron has developed the drug through its advanced VelocImmune technology, which uses a unique genetically-humanized mouse to produce optimised fully human antibodies.

Dupixent has received the FDA breakthrough therapy designation for the treatment of severe atopic dermatitis in children six months to 11 years of age not well controlled on topical prescription medications.

The drug has been previously approved in the US, for atopic dermatitis patients aged 12 years and older, where the disease cannot be controlled with topical prescription therapies.

In addition, the drug is indicated for use with other asthma medicines for the maintenance treatment of eosinophilic or oral steroid-dependent asthma in patients aged 12 years and older, whose asthma is not controlled with asthma medicines.

The sBLA for Dupixent is based on data from clinical trials including Phase 3 efficacy and safety study of Dupixent plus topical corticosteroids (TCS) in children with severe atopic dermatitis, which demonstrated positive results.

Conjunctivitis, nasopharyngitis and injection site reactions included the adverse events more commonly observed in the trial. The drug has shown a safety profile consistent with the previous one in older populations.