June 19, 2020: The National Medical Products Administration (NMPA) in China has approved Dupixent® (dupilumab) for the treatment of moderate-to-severe atopic dermatitis in adults whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.
The NMPA identified Dupixent as an overseas medicine considered urgently needed in clinical practice, leading to an expedited review and approval process.
“The limited treatment options in China for moderate-to-severe atopic dermatitis has left many patients and those who care for them coping with the physical and emotional burden of the disease,” said Professor Zhang Jianzhong, chairman of the 13th session of the Dermatology and Venereology Branch of the Chinese Medical Association, and director of the Department of Dermatology, Peking University People’s Hospital.
“The availability of a targeted treatment like Dupixent provides hope to those seeking relief from the often-unbearable itch and other symptoms that can significantly impact the lives of adults living with this chronic disease.”
Atopic dermatitis is a chronic inflammatory disease that often appears as a rash on the skin.
Moderate-to-severe atopic dermatitis is characterized by rashes that can potentially cover much of the body, and can include intense, persistent itching, skin dryness and skin lesions including cracking, redness or darkness, crusting and oozing.
Itch is one of the most burdensome symptoms for patients and can be debilitating.
Inadequately controlled atopic dermatitis can have a physical, emotional and psychosocial impact, causing sleep disturbance, symptoms of anxiety and depression, and feelings of isolation.
“Sanofi has deep roots in China, and it continues to be a significant area of growth for us. New regulations have paved the way for first-in-class treatments like Dupixent to be delivered to patients sooner and, in partnership with the government’s Healthy China 2030 initiative, we plan to seek approval by 2025 for more than 25 innovative medicines for chronic and rare diseases and vaccines,” said Paul Hudson, Chief Executive Officer, Sanofi.
“The approval of Dupixent in China offers a new treatment option with an established safety and efficacy profile. This is a meaningful advance for patients and their physicians who have struggled to treat the debilitating symptoms of moderate-to-severe atopic dermatitis which can seriously impact quality of life.”
Dupixent is a fully-human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) proteins, and is not an immunosuppressant.
Data from Dupixent clinical trials have shown that IL-4 and IL-13 are key drivers of the type 2 inflammation that plays a major role in atopic dermatitis, asthma and chronic rhinosinusitis with nasal polyposis (CRSwNP).
“As the first biologic medicine approved for moderate-to-severe atopic dermatitis, Dupixent has transformed the treatment landscape for patients around the world by targeting the type 2 inflammation that underlies the disease, rather than broadly suppressing the immune system,” said George D. Yancopoulos, M.D., Ph.D., Co-founder, President and Chief Scientific Officer of Regeneron.
“More than 150,000 people have already been treated with Dupixent globally and today’s approval brings this novel treatment to those in China who are in urgent need of new options.”
The approval was based on positive data from the global LIBERTY AD clinical trial program that included nearly 3,000 patients with inadequately controlled moderate-to-severe atopic dermatitis.
The trials evaluated Dupixent (monotherapy or in combination with topical corticosteroids) on safety and efficacy measures, including skin clearance, overall disease severity and itch.
Data from an ongoing Phase 3 trial in China of adults with moderate-to-severe atopic dermatitis will be shared with NMPA in the second half of 2020 when the trial has completed.
Dupixent will be available in China in a 300 mg dose as a pre-filled syringe. Dupixent is intended for injection under the skin (subcutaneous injection) and is given every other week following an initial loading dose.
It can be given in a clinic or at home by self-administration after training by a healthcare professional. Dupixent can be used with or without topical corticosteroids.
Dupixent is currently approved in the U.S., Europe, Japan and other countries around the world for use in specific patients with moderate-to-severe atopic dermatitis, as well as certain patients with asthma or CRSwNP in different age populations.
Dupilumab Development Program
To date, dupilumab has been studied in more than 10,000 patients across 50 clinical trials in various chronic diseases driven by type 2 inflammation.
In addition to the currently approved indications, Sanofi and Regeneron are also studying dupilumab in a broad range of clinical development programs for diseases driven by allergic and other type 2 inflammation, including pediatric asthma (6 to 11 years of age, Phase 3), pediatric atopic dermatitis (6 months to 5 years of age, Phase 2/3), eosinophilic esophagitis (Phase 3), chronic obstructive pulmonary disease (Phase 3), bullous pemphigoid (Phase 3), prurigo nodularis (Phase 3), chronic spontaneous urticaria (Phase 3), and food and environmental allergies (Phase 2).
These potential uses are investigational, and the safety and efficacy have not been evaluated by any regulatory authority. Dupilumab is being jointly developed by Sanofi and Regeneron under a global collaboration agreement.
Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to seven FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories.
Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, pain, infectious diseases and rare diseases.
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