Sanofi Genzyme Korea, the specialty care division of the French pharmaceutical firm, said it got the Ministry of Food and Drug Safety’s marketing approval Friday for its atopic dermatitis treatment Dupixent (dupilumab).
Dupixent is the first targeted biologic therapy for adult patients who have moderate-to-severe atopic dermatitis who do not benefit from or cannot tolerate topical treatments. The injection selectively inhibits interleukin-3 and interleukin-4 proteins, which are the causes of adult atopic dermatitis, Sanofi Genzyme Korea said.
The subcutaneous injection, developed jointly by Sanofi and Regeneron, is administered first in a single 600-mg dose and then in 300-mg doses every two weeks after. It can be administered alone or with a topical corticosteroid.
Commonly referred to as eczema, atopic dermatitis can cause the skin to develop red, scaly and crusted bumps that are often itchy. Doctors often prescribe corticosteroid creams to lessen inflammation and patients usually use over-the-counter medication to alleviate symptoms.
Dupixent has been shown to be effective in treating moderate-to-severe adult atopic dermatitis by demonstrating safety and tolerability profiles through a 52-week large-scale clinical study, the company said. Findings from phase 3 studies, SOLO1 and SOLO2, were also published in the New England Journal of Medicine (NEJM).
“Dupixent’s licensing in the domestic market has allowed Sanofi’s corporate vision, Empowering Life, to change the lives of patients with moderate-to-severe adult atopic dermatitis, a chronic systemic immune disorder that has been difficult to treat, and their families,” said Park Hee-kyung, CEO of Genzyme Korea.
Dupixent has been approved for marketing in the U.S., Canada, the European Union, Japan, and Australia. The drug was the first skin disease therapy to obtain the U.S. Food and Drug Administration (FDA)’s designation as a breakthrough therapy in 2014, according to Sanofi Genzyme Korea.
<© Korea Biomedical Review, All rights reserved.>