News from the FDA/CDC

FDA approves dupilumab for treatment of prurigo nodularis


The Food and Drug Administration has approved dupilumab for treating adults with prurigo nodularis, the first treatment approved for this indication, according to a press release from the manufacturers.

Recent studies of dupilumab (Dupixent), which inhibits the signaling of the interleukin-4 and IL-13 pathways, show significant improvements in both itchiness and lesion counts, compared with placebo, in adults with prurigo nodularis (PN).

Approval was based on data from two randomized, controlled trials, PRIME and PRIME2, comparing dupilumab with placebo in 311 adults with uncontrolled PN, according to the release issued by Regeneron and Sanofi. Dupilumab is administered via a 300 mg subcutaneous injection every 2 weeks after a loading dose.

The primary endpoint in PRIME and PRIME 2 was a clinically meaningful improvement in itch from baseline as measured by at least a 4-point reduction in the Worst Itch Numeric Rating Scale, a 0-10 scale, at 24 and 12 weeks, respectively. In the studies, 60% and 58% of patients treated with dupilumab met the primary endpoint at 24 weeks, compared with 18% and 20% of those on placebo. At 24 weeks, 48% and 45% of patients on dupilumab achieved clear or almost clear skin, another study endpoint, compared with 18% and 16% among those on placebo.*

In PRIME and PRIME2, 44% and 37% of patients on dupilumab met the primary endpoint at 12 weeks versus16% and 22% among those on placebo.

Safety profiles were similar to those seen in other dupilumab studies, according to the release. The most common adverse events in the two studies combined were nasopharyngitis, reported in 5% of those on dupilumab versus 2% of those on placebo; conjunctivitis in 4% versus 1%; herpes infection in 3% versus 0; dizziness in 3% vs. 1%; muscle pain in 3% versus 1%; and diarrhea in 3% versus 1%.

Phase 3 data on dupilumab for PN were recently presented at the annual congress of the European Academy of Dermatology and Venereology.

A regulatory submission for dupilumab for treating PN is in progress at the European Medicines Agency, and submissions are planned to regulatory agencies in additional countries later in 2022, according to the company press release.

Dupilumab is currently approved in the United States for atopic dermatitis in children aged 6 months and older and adults with moderate to severe atopic dermatitis and in children and adults aged 6 years and older with moderate to severe eosinophilic or oral steroid-dependent asthma, as well as for the treatment of chronic rhinosinusitis with nasal polyposis in adults, and for the treatment of eosinophilic esophagitis in adults and children aged 12 years and older, weighing at least 40 kg. Dupilumab is under clinical development for the treatment of chronic spontaneous urticaria and bullous pemphigoid, according to the manufacturers.

The studies were supported by Regeneron and Sanofi.

A version of this article first appeared on

*Correction, 9/30/22: An earlier version of this article misstated results of one endpoint.

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