The US Food and Drug Administration (FDA) announces its approval of Dupixent (dupilumab), an injectable drug to treat adults with moderate-to-severe eczema (atopic dermatitis).
Three placebo-controlled clinical trials with a total of 2,119 adult participants with moderate-to-severe atopic dermatitis not adequately controlled by topical medication(s) established the safety and efficacy of Dupixent. Overall, participants who received Dupixent achieved greater response, defined as clear or almost clear skin, and experienced a reduction in itch after 16 weeks of treatment.
“FDA’s approval of Dupixent demonstrates our commitment to approving new and innovative therapies for patients with skin disease,” says Julie Beitz, MD, director of the Office of Drug Evaluation III in the FDA’s Center for Drug Evaluation and Research, in the FDA release. “Eczema can cause significant skin irritation and discomfort for patients, so it is important to have a variety of treatment options available to patients, including those patients whose disease is not controlled by topical therapies.”
Dupixent received Priority Review status by the FDA, which is reserved for medicines that could represent potentially significant improvements in safety or efficacy in treating serious conditions. This followed the drug’s previous designation as a Breakthrough Therapy, given in 2014, for inadequately controlled moderate-to-severe atopic dermatitis, according to a separate media release from Sanofi.
“People with moderate-to-severe atopic dermatitis cope with intense, sometimes unbearable symptoms that can impact them for most of their lives,” says Julie Block, president and chief executive officer, National Eczema Association, in the Sanofi media release.
“To date, there have been few options available to treat people with moderate-to-severe atopic dermatitis who have uncontrolled disease. That’s why today’s approval of Dupixent is so important for our community. Now we have a treatment that is expected to help address patients suffering from this devastating disease,” she adds.
Sanofi Genzyme—the specialty care global business unit of Sanofi—and Regeneron Phamaceuticals Inc will market Dupixent in the United States, the release adds.
[Source(s): US Food and Drug Administration, Sanofi, PR Newswire]