Dupixent (dupilumab), given as a subcutaneous injection, is the first drug approved by the FDA for this indication.
Prurigo nodularis, a chronic debilitating inflammatory skin disease that causes extreme quality of life disruptions, affects approximately 75,000 adults in the United States, who are most in need of new treatment options.
“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, MD, head of global development in immunology and inflammation at Sanofi, said in the 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 was based on data from the PRIME and PRIME2 phase 3 clinical trials in which patients with prurigo nodularis treated with Dupixent were statistically more likely to experience reductions in itch and skin clearance than those treated with placebo.
At 24 weeks, a clinically meaningful reduction in itch from baseline was reported in 60% and 58% of those treated with Dupixent, compared with 18% and 20% treated with placebo.
Dupixent has previously been approved by the FDA for the treatment of atopic dermatitis,
eosinophilic or oral steroid dependent asthma, chronic rhinosinusitis and eosinophilic esophagitis.