Sanofi’s Dupixent scores Chinese approval in moderate to severe atopic dermatitis

pharmafile | June 22, 2020 | News story | Sales and Marketing China, Dupixent, Sanofi, atopic dermatitis, pharma 

China’s National Medical Products Administration (NMPA) has moved to approve a 300mg pre-filled pen formulation of Sanofi and Regeneron’s Dupixent (dupilumab), it has emerged, for the treatment of moderate to severe atopic dermatitis (AD).

The Chinese regulator awarded approval specifically to adult patients for whom topical prescription therapies are inadvisable or ineffective, following an accelerated review after identifying the therapy as one urgently needed in clinical practice.

“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,” commented Professor Zhang Jianzhong, Chairman of the 13th Session of the Dermatology and Venereology Branch of the Chinese Medical Association, and Director of Department of Dermatology at 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.”

The decision was based on positive data drawn from 3,000 patients with moderate to severe AD evaluating the efficacy of Dupixent either alone or in combination with topical corticosteroids. A Phase 3 study is ongoing in this indication, with data due to be shared with the NMPA in the latter half of this year.

“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,” remarked Dr George D Yancopoulos, Co-founder, President and Chief Scientific Officer at 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.”

Dupixent has already been widely approved around the world in moderate to severe AD, including in Europe, the US, and Japan.

Matt Fellows

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