Dupixent approved for prurigo nodularis treatment
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The FDA has approved Dupixent for the treatment of prurigo nodularis in adults, Regeneron and Sanofi announced in a press release.
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.
Perspective
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Dupilumab is the first targeted treatment approved for prurigo nodularis. Prurigo nodularis is one of the most challenging chronic itchy conditions in dermatology, as patients suffer from unrelenting itch and disfiguring nodules with significant impact on their quality of life. The approval of dupilumab, which demonstrated in two phase 3 trials a robust anti-pruritic effect as well as eliminating the nodules with an excellent safety profile, will offer these miserable patients a new life.
Currently there were no drugs approved for this debilitating condition that affects hundreds of thousands of U.S. patients, and the off-label use of numerous drugs demonstrated limited efficacy and many adverse effects.
This approval opens a new era for drug developments of treatments focused on chronic itch of different etiologies of itch where prurigo nodularis is the classical prototype.
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