Dupixent is a fully-human monoclonal antibody discovered using Regeneron's original VelocImmune technology

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Regeneron Pharmaceuticals headquarters under construction, 2014. (Credit: Jim.henderson/Wikipedia.)

Regeneron Pharmaceuticals and Sanofi have obtained an expanded European Commission (EC) approval for Dupixent (dupilumab) to include treatment of severe atopic dermatitis in children aged between six and 11 years, who are eligible for systemic therapy.

Dupixent is a fully-human monoclonal antibody discovered using Regeneron’s original VelocImmune technology. It targets the signalling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) proteins, and is not an immunosuppressant.

In the clinical trials, the drug showed effectiveness in treating atopic dermatitis, asthma and chronic rhinosinusitis with nasal polyposis (CRSwNP), and is currently approved in more than 60 countries around the world.

Dupixent is claimed to be the only systemic medicine approved to treat patients with severe atopic dermatitis in the EU.

Regeneron president and chief scientific officer George Yancopoulos said: “This approval for Dupixent in the EU represents a major advancement for children with severe atopic dermatitis and their families, who spend countless days and nights tending to their child’s disease with few treatment options to help alleviate the debilitating symptoms.

“Dupixent is a novel therapy that addresses a root cause of atopic dermatitis by specifically targeting the underlying type 2 inflammation of the disease.

“Dupixent has already been used by hundreds of thousands of patients around the world, including those with atopic dermatitis as well as other type 2 inflammatory diseases such as asthma and adults with chronic rhinosinusitis with nasal polyps.”

Atopic dermatitis is a chronic inflammatory disease of the skin that impacts several aspects of life in both children and their families.

The current standard of care for children with severe atopic dermatitis in Europe is limited to topical treatments, which makes children with poorly-controlled disease to cope with intense, unrelenting itch and skin lesions.

Also, uncontrolled severe atopic dermatitis may pose an emotional and psychosocial impact, and causes sleep disturbance, anxiety and depression, and feelings of isolation in children.

The expanded EC approval is based on data from Phase 3 efficacy and safety study of Dupixent plus topical corticosteroids (TCS) compared to TCS alone (placebo) in paediatric severe atopic dermatitis patients, aged between six and 11 years.

In the study, treatment using Dupixent 300mg administered as subcutaneous injection for every four weeks resulted in improved disease severity, skin clearance, health-related quality of life (HR-QoL), and reduced the itching.

Dupixent showed a similar safety profile in paediatric patients followed through week 52, compared to the safety profile at week 16 and is consistent with the safety profile observed in adults and adolescents with atopic dermatitis.

Sanofi research and development global head John Reed said: “The approval of Dupixent for children in Europe marks another significant milestone for atopic dermatitis patients and their families, broadening the availability of a first-in-class medicine that offers a proven safe and effective treatment for this debilitating skin disease.

“Dupixent’s ability to provide significantly clearer skin, and clinically meaningful reduction of persistent itch, addresses important unmet needs for these children. In addition to atopic dermatitis, we continue to investigate the potential of Dupixent in younger age groups and across a variety of type 2 inflammatory diseases.”