Regeneron and Sanofi announce positive dupilumab topline results from two Phase III trials

Dupilumab is first systemic therapy to show positive Phase III results in patients with moderate-to-severe atopic dermatitis, a serious, chronic inflammatory skin disease marked by widespread rash, itching and associated psychosocial comorbidities.

"These are the first Phase III studies of a systemic therapy to demonstrate a significant improvement in moderate-to-severe atopic dermatitis, a chronic, debilitating inflammatory disease that impacts over one million Americans," said George D. Yancopoulos, Chief Scientific Officer of Regeneron and President of Regeneron Laboratories. "These data provide strong evidence that the IL-4 and IL-13 signaling pathway is a fundamental driver of inflammation in atopic dermatitis. Dupilumab is the first in a new class of immunotherapies — in these 16 week trials, dupilumab blocked the aberrant activation of this pathway, resulting in significant efficacy without evidence of immune-suppressing side effects. We continue to evaluate the role of IL-4 and IL-13 signaling in related inflammatory conditions, including asthma and nasal polyposis, where we have ongoing dupilumab clinical development."

"There are no approved systemic therapies in the US for people with moderate-to-severe atopic dermatitis, underscoring the clear unmet need. These results may bring new hope to atopic dermatitis patients, many of whom have suffered for years," said Elias Zerhouni, President, Global R&D, Sanofi. "In the US, where dupilumab in AD has been granted Breakthrough Therapy designation by the FDA, we plan to submit a regulatory application in the third quarter of this year and will work to bring this innovative therapy to patients as quickly as possible."