Regeneron Pharmaceuticals Inc. of Westchester has received approval to market and manufacture its antibody drug Dupixent in Japan for the treatment of atopic dermatitis in adults not adequately controlled with existing therapies.
Dupixent is the brand name for dupilumab, a human monoclonal antibody jointly developed by Regeneron, the state’s largest biotechnology employer, and the French pharmaceutical company Sanofi under a global collaboration agreement. It will be commercialized in Japan by Sanofi, Regeneron said in its Monday announcement.
A form of eczema, atopic dermatitis 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 debilitating.
Regeneron officials said Dupixent specifically targets and inhibits signaling of two key proteins believed to be important contributors of the persistent underlying inflammation in atopic dermatitis and certain other allergic or atopic diseases. The U.S. Food & Drug Administration last March approved the drug 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 FDA approval was followed in September by the European Commission’s marketing authorization for Dupixent for use in adults with moderate-to-severe atopic dermatitis who are candidates for systemic therapy.
Dupixent will come in a 300-milligran pre-filled syringe and be delivered as a subcutaneous injection every other week after an initial loading dose.