Dupilumab Gets First FDA-Approved Indication for Prurigo Nodularis

The FDA has approved dupilumab (Dupixent) as the first treatment with an indication for prurigo nodularis, Sanofi announced.

A chronic inflammatory skin condition affecting about 75,000 Americans, prurigo nodularis causes persistent intense itch associated with nodular skin lesions that can cover most of the body. The condition can lead to significant debility and can have a negative impact on mental health and quality of life that ranks among the highest associated with skin diseases. In the absence of approved therapies, dermatologists have used a variety of systemic and topical interventions with limited success.

“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,” said Naimish Patel, MD, head of global development, immunology and inflammation, at Sanofi. “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.”

Support for the approval came from the phase III placebo-controlled PRIME and PRIME2 trials that evaluated the safety and efficacy of dupilumab in adults with prurigo nodularis. Data from the two trials showed that about three times as many patients treated with dupilumab had clinically meaningful improvement in itch and nodules at 24 weeks compared with placebo (~60% vs ~20%). More than twice as many patients had complete or almost complete skin clearance (45-48% vs 16-18%) and about four times as many patients had both clinically meaningful reduction in itch and clear or almost clear skin (32-39% vs 9%).

No new or unexpected adverse events (AEs) occurred during either clinical trial. The most common AEs that occurred more often with dupilumab than placebo were nasopharyngitis (5% vs 2%), conjunctivitis (4% vs 1%), herpes infection (3% vs 0%), dizziness (3% vs 1%), muscle pain (3% vs 1%), and diarrhea (3% vs 1%).

Prurigo nodularis arises from underlying type 2 inflammation. Dupilumab reduces inflammation by simultaneously targeting interleukin (IL)-4 and IL-13. The approval is the fifth in the U.S., following approvals for atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis, and eosinophilic esophagitis.

“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,” Patel noted.