Dupilumab (Dupixent®) Approved in China for Infants Aged 6 Months and Older with Moderate-to-Severe Atopic Dermatitis, Becoming the First and Only Biologic for Full Age Spectrum Coverage

 -- Covering all age groups, becomingFirst-in-classCan be used forInfants and ToddlersTherapeutic Biologics

ShanghaiMay 30, 2023PR Newswire -- Sanofi announced today that Dupixent® (dupilumab injection) has been approved by the National Medical Products Administration (NMPA) of China for use in infants and young children aged 6 months to 5 years with moderate-to-severe atopic dermatitis (AD). This is currently the first and only targeted biologic approved for the treatment of moderate-to-severe atopic dermatitis across the full age spectrum from infancy to adulthood, and it is also the first biologic treatment available for infants aged 6 months and above.

Professor Ma Lin, Director of the Department of Dermatology, Beijing Children's Hospital, Capital Medical University"The healthy physical and mental growth of infants and young children is fundamental to the sustainable development of our nation's future. AD may affect their growth and development, sleep, cognitive function, attention, and more. Therefore, when an infant or young child suffers from AD, the entire family is disturbed, imposing a significant disease burden on the child as well as their parents and caregivers. However, treating atopic dermatitis in infants and young children is not easy; both efficacy and long-term safety must be considered. The approval of Dupixent® for use in infants and young children provides an opportunity for younger patients to thrive early in life, helping them overcome unbearable itching and skin lesions while offering clinicians a safe and effective treatment option, filling the gap in systemic treatment for these young patients."

Atopic dermatitis is a systemic immune disease caused by type 2 inflammatory reactions, characterized by chronic, inflammatory, and recurrent features. Most patients develop it from persistent infantile eczema.^[1],[2]Over the past decade, the prevalence of atopic dermatitis (AD) in China has been continuously increasing, with higher incidence rates in younger age groups. The prevalence of atopic dermatitis in children aged 1-7 is 12.94%.^[3]The prevalence rate in infants under 1 year old is as high as 30.48%.^[4]During the long-term treatment process, patients look forward to treatment methods that are both effective and safe over the long term. The recent approval of Dupixent® for the treatment of atopic dermatitis in infants and young children provides a new treatment option for this patient group.

Research data shows that 85%-90% of atopic dermatitis patients develop the condition before the age of 5.^[5], symptoms often persist into adulthood, including persistent severe itching, dry and cracked skin, edematous erythema, exudation, crusting, etc., while also increasing the risk of skin infections.

Mechanistically speaking, Dupixent® as an innovative biologic targets the root cause by precisely acting on the signaling of key pathogenic factors IL-4 and IL-13, thereby inhibiting inflammation at its source. Since June 2020, when Dupixent® was approved for use in treating adult patients with atopic dermatitis, within three years, the eligible patient population for Dupixent® has expanded from adults to infants as young as six months old. This means that Dupixent® is now indicated for nearly all age groups for the treatment of atopic dermatitis.

This approval was based on a pivotal Phase III clinical trial conducted in 162 children, which showed that, compared with topical corticosteroids (TCS), Dupixent® combined with low-potency TCS enabled 28% of children to regain clear skin, while the corresponding data for TCS was only 4%. Additionally, 53% of pediatric patients treated with Dupixent® experienced over 75% improvement in their condition, compared to only 11% in the placebo group.^[6]The positive results of this Phase III clinical trial indicate that Dupixent® in combination with topical corticosteroids (TCS) can significantly improve skin lesions in children aged 6 months to 5 years with inadequately controlled moderate-to-severe atopic dermatitis, while reducing overall disease severity and alleviating itching.

Xie Lijuan, General Manager of Sanofi's Global Specialty Division in China, said:"We are proud to witness Dupixent® expanding its atopic dermatitis indications in China to include infants and young children, becoming the first biologic available for such a young age group, further confirming the outstanding clinical benefits and safety of this transformative therapy, and ushering in a new chapter in the treatment of atopic dermatitis in infants and young children in China. In the future, Sanofi will continue to deepen its expertise in the field of Type 2 inflammatory diseases, transform medical practices, better serve patients in China, and meet the health needs of more patients."

Dupixent® has been approved in more than sixty countries and regions worldwide. As the first targeted biologic for the treatment of moderate-to-severe atopic dermatitis, it has effectively treated over 600,000 patients. In May 2019, Dupixent® was included in the second batch of clinically urgently needed overseas new drugs list by the Center for Drug Evaluation (CDE) under the National Medical Products Administration (NMPA), accelerating the approval process. One year later, Dupixent® received approval from China’s NMPA for the treatment of adult patients with moderate-to-severe atopic dermatitis and was included in the 2020 National Reimbursement Drug List (NRDL), reducing the financial burden on patients. Subsequently, Dupixent® was further approved to treat adolescent patients aged 12-17 with atopic dermatitis, followed by patients aged 6 years and above, and most recently, infants and young children with atopic dermatitis. Each step reflects the "China speed" in making innovative drugs rapidly accessible.