FDA Approves Dupilumab, a Potential Blockbuster for Atopic Dermatitis

Dupilumab, a drug considered extremely promising for the treatment of atopic dermatitis (AD), was today approved for treatment of the skin condition by the US Food and Drug Administration (FDA).

Fast-tracked by the FDA in September of 2016, the drug has elicited a great deal of anticipation. In the SOLO1 and SOLO2 trials, published in The New England Journal of Medicine in October, a significantly greater portion of those who received dupilumab saw a reduction in Eczema Area and Severity Index (EASI) by 75% after 16 weeks than those who received placebo.

Eric Simpson, the lead author on those studies, spoke to MD Magazine not long after their release. “I was quite surprised in the earlier phase trials we performed on the drug,” he said. “It was not clear which chemical messengers were most important in this condition as there are so many abnormalities you can find in the skin of affected patients. After many years of trying by many companies, Regeneron and Sanofi found two very important mediators of the disease.”

A fully human monoclonal antibody directed against the body’s interleukin (IL)-4 receptors, dupilumab is intended to block signaling of IL-4 and IL-13. Both are cytokines believed to play a major role in the manifestation of allergic diseases, and the drug is being considered for other applications, including the treatment of asthma.

“There are no approved therapies for AD in the United States, outside of oral corticosteroids, a treatment discouraged by all treatment guidelines across the globe. There will be cheaper options to treat atopic dermatitis systemically, but they do not show the same level of effectiveness and are limited by significant side effects,” Simpson said.

Earlier this month, the United Kingdom accepted it to be tried in it Early Access to Medicines Scheme, which gives patients with severe manifestations of given conditions that cannot receive adequate treatment with current drugs access to newer therapies yet to be confirmed by the European Medicines Agency (EMA). The EMA is also currently reviewing dupilumab for approval.

A joint venture of aforementioned titans Sanofi and Regeneron, the drug will be marketed as Dupixent and is expected to be a blockbuster, with annual sales predicted in the billions of dollars. Speaking to MD Magazine at the American Academy of Allergy, Asthma, and Immunology 2017 meeting, Regeneron’s Executive Director Bola Akinlade, MD, indicated the drug would fundamentally impact the care of moderate to severe AD. “There really has not been an approved, systemic treatment for moderate to severe atopic dermatitis…dupilumab certainly would be a very revolutionary treatment.”

"Not only has it shown efficacy in atopic dermatitis, but dupilumab also has shown efficacy in related atopic dermatitis conditions such as asthma and nasal polyps," said Akinlade.

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