This approval makes Dupixent the first and only medicine available in the US for the treatment of prurigo nodularis, a chronic and debilitating skin disease.
A fully human monoclonal antibody, Dupixent blocks the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways signalling.
It previously received regulatory approvals in many countries for several indications, including asthma, chronic rhinosinusitis with nasal polyposis (CRSwNP), atopic dermatitis, and eosinophilic esophagitis (EoE), among others.
Sanofi Global Development, Immunology and Inflammation head Naimish Patel said: “Until today, there were limited treatment options to manage the relentless itch and associated sensations of burning and stinging skin that can negatively impact the lives of patients struggling with prurigo nodularis.
“Dupixent has the potential to transform the standard-of-care for prurigo nodularis patients by alleviating the key hallmarks of the disease, such as reducing itch and achieving clearer skin.
“With Dupixent now approved in two diseases in dermatology where type 2 inflammation is a central driver, we look forward to further evaluating the potential of inhibiting IL-4 and IL-13 in other chronic skin diseases.”
The regulatory approval is based on the data obtained from two Phase III trials, PRIME and PRIME2.
The two double-blind, placebo-controlled trials have assessed the Dupixent’s efficacy and safety in 311 adult patients with uncontrolled prurigo nodularis.
The findings from Phase III PRIME and PRIME2 studies demonstrated that nearly 60% and 58% patients treated with Dupixent experienced reduction in itch from baseline compared with 18% and 20% for placebo at 24 weeks. About 48% and 45% Dupixent patients achieved clear or almost clear skin compared with 18% and 16% for placebo at 24 weeks.
Nasopharyngitis, conjunctivitis, herpes infection, dizziness, muscle pain, and diarrhea are the most common adverse events observed with Dupixent.