BRIEF—Atopic dermatitis drug Dupixent approved in Japan

Japan’s Ministry of Health, Labor and Welfare (MHLW) has granted marketing and manufacturing authorization for Dupixent (dupilumab) for the treatment of atopic dermatitis in adults not adequately controlled with existing therapies.

Dupixent, which is slated to reach peak global sales of at least $4 billion, is being jointly developed by US biotech Regeneron Pharmaceuticals and France’s Sanofi under a global collaboration agreement, and will be commercialized in Japan by Sanofi.

Dupixent is a human monoclonal antibody designed to specifically inhibit signaling of two key proteins, interleukin (IL)-4 and IL-13, which are believed to be important contributors of the persistent underlying inflammation in atopic dermatitis, and certain other allergic or atopic diseases.

In March 2017, the US Food and Drug Administration approved Dupixent in the USA for the treatment of adults with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.

The European Commission also granted marketing authorization for Dupixent for use in adults with moderate-to-severe atopic dermatitis who are candidates for systemic therapy in September 2017.