FDA Approves Duxipent for Rare Skin Disorder

The FDA has approved Dupixent (dupilumab) injection for the treatment of adults with prurigo nodularis (PN). This is the first FDA-approved treatment for prurigo nodularis, a skin disease that causes hard, itchy nodules to form on the skin. The itching can be intense, causing people to scratch themselves to the point of bleeding or pain. The disease affects about 87,000 adults per year according to the National Organization for Rare Diseases database.

This approval represents the second dermatology indication for Dupixent and fifth disease indication overall in the United States. Developed by Sanofi and Regeneron Pharmaceuticals, Dupixent is a human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways and is not an immunosuppressant. It is approved for multiple indications, including treatment of atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis, and eosinophilic esophagitis. Dupixent’s most recent approval was in June 2022 for children aged 6 months to 5 years with moderate-to-severe atopic dermatitis.

Dupixent comes as a single-dose pre-filled syringe with needle shield or as a pre-filled pen and is given as an injection under the skin.

Related: FDA Approves Dupixent for Young Children with Atopic Dermatitis

Naimish Patel, M.D.

“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,” Naimish Patel, M.D., head of global development, immunology and inflammation at Sanofi, said in a press release. “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.”

The approval for the prurigo nodularis indication was based on two phase 3 trials, PRIME and PRIME2, evaluating the efficacy and safety of Dupixent in adults with prurigo nodularis. Efficacy in these trials assessed the proportion of subjects with clinically meaningful reduction in itch, clearing of skin, or both.

In the trials, about three times as many Dupixent patients (60% and 58%) experienced a clinically meaningful reduction in itch from baseline at 24 weeks, compared with 18% and 20% for placebo, the primary endpoint in PRIME. Additionally, 44% and 37% of Dupixent patients experienced a clinically meaningful reduction in itch from baseline at 12 weeks, compared with 16% and 22% for placebo, the primary endpoint in PRIME2. More than twice as many Dupixent patients (48% and 45%) achieved clear or almost clear skin at 24 weeks, compared with 18% and 16% for placebo.

The most common adverse events from pooled from data in both studies were nasopharyngitis, conjunctivitis, herpes infection, dizziness, muscle pain, and diarrhea.