FDA Approves Dupilumab for Adult Patients With Prurigo Nodularis

The FDA has approved dupilumab (Dupixent; Regeneron Pharmaceuticals, Inc and Sanofi ) for the treatment of adult patients with prurigo nodularis.

Dupilumab is the first and only medicine approved specifically for the treatment of prurigo nodularis in the United States. The chronic, debilitating skin disease with underlying type 2 inflammation has one of the greatest negative impacts on quality of life among inflammatory skin diseases.

"Patients living with prurigo nodularis must often contend with dozens, if not hundreds, of itchy and painful nodules covering their body and have not had an approved treatment option for their disease," said George D. Yancopoulos, MD, PhD, president and chief scientific officer at Regeneron, in a press release. "Dupixent has already transformed the treatment landscape of several diseases driven by type 2 inflammation—including atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis and eosinophilic esophagitis—and been prescribed to more than half a million patients around the world for its approved indications. With this approval, those suffering with prurigo nodularis finally have a medicine to address the debilitating signs and symptoms of the disease."

Dupilumab is administered via subcutaneous injection at different sites. In patients 18 years of age and older with prurigo nodularis, a 300 mg dose is administered via pre-filled syringe or pre-filled pen every 2 weeks after an initial loading dose.

The approval was based on data the phase 3 PRIME and PRIME2 trials, which analyzed the efficacy and safety of dupilumab in adults with prurigo nodularis. Efficacy measures in the studies evaluated the proportion of patients who experienced a clinically meaningful decrease in itch, clearing of skin, or both.

The double-blind, placebo-controlled trials enrolled 311 adult patients with uncontrolled prurigo nodularis. The primary endpoint of both trials analyzed the proportion of patients with a clinically meaningful improvement in itch from baseline (measured by a ≥4-point reduction in Worst-Itch Numeric Rating Scale [WI-NRS] on a 0-10 scale) at 24 and 12 weeks, respectively. Secondary endpoints included the proportion of patients with clear or almost clear skin of nodules at 24 weeks (measured by a score of 0 or 1 on the Investigator's Global Assessment PN-Stage [IGA PN-S] on a 0-4 scale), and the proportion of patients who experienced a clinically meaningful response in both WI-NRS and IGA PN-S.

In the PRIME trial, approximately 3 times as many patients treated with dupilumab, 60% and 58, experienced a clinically meaningful reduction in itch from baseline at 24 weeks, vs 18% and 20% for placebo.

In PRIME2, 44% and 37% of patients in the dupilumab group had a clinically meaningful decrease in itch from baseline at 12 weeks, vs 16% and 22% for placebo. More than twice as many patients (48% and 45%) treated with dupilumab experienced clear or almost clear skin at 24 weeks, vs 18% and 16% for placebo.

Further, more than 3 times as many patients administered dupilumab (39% and 32%) had a clinically meaningful decrease in itch and clear or almost clear skin, vs 9% and 9% of patients in the placebo group at 24 weeks.

Safety findings were consistent with the known safety profile of dupilumab in its approved dermatology indication. The most common adverse events (≥2%) more frequently observed with dupilumab were nasopharyngitis (5% dupilumab, 2% placebo), conjunctivitis (4% dupilumab, 1% placebo), herpes infection (3% dupilumab, 0% placebo), dizziness (3% dupilumab, 1% placebo), muscle pain (3% dupilumab, 1% placebo), and diarrhea (3% dupilumab, 1% placebo).

"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, 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. 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."

Reference

Dupixent® (Dupilumab) Approved by FDA as the First and Only Treatment Indicated for Prurigo Nodularis. Regeneron. News release. September 28, 2022. https://investor.regeneron.com/news-releases/news-release-details/dupixentr-dupilumab-approved-fda-first-and-only-treatment