Japan’s MHLW extended marketing and manufacturing authorization for Regeneron’s DUPIXENT

Japan’s Ministry of health, labor and Welfare extended marketing and manufacturing authorization for Regeneron’s DUPIXENT for the treatment of atopic dermatitis in adults not curbed by existing therapies.

DUPIXENT is a human monoclonal antibody designed to specifically inhibit signaling of two key proteins, 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. DUPIXENT will come in a 300mg pre-filled syringe and be delivered as a subcutaneous injection every other week after an initial loading dose. DUPIXENT can be used with or without topical corticosteroids.

Atopic dermatitis (AD), a form of eczema, is a chronic inflammatory disease with symptoms often appearing as a rash on the skin. Moderate-to-severe atopic dermatitis is characterized by rashes sometimes covering much of the body, and can include intense, persistent itching and skin dryness, cracking, redness, crusting and oozing. Itch is one of the most burdensome symptoms for patients and can be catastrophic.

Image Source: Regeneron