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FDA Approves Dupliumab for Prurigo Nodularis


Sanofi and Regeneron’s dupliumab will provide relief to patients with extreme itch and skin lesions.

The US Food and Drug Administration has approved dupliumab (Dupixent; Sanofi and Regeron Phamaceuticals, Inc.) for the treatment of prurigo nodularis in adult patients. Dermatology Times© spoke with dermatologists Amy Spizuoco, DO, FAOCD, a dual board-certified dermatologist and owner of True Dermatology in New York, New York and Christopher Bunick, MD. PhD, associate professor of dermatology, Yale Department of Dermatology, to discuss how they believes dupliumab will change the way dermatologists treat prurigo nodularis. 

Spizuoco: This is huge for us in the dermatology community, because patients who have prurigo nodularis suffer from extreme itching and skin lesions andup until now, we've not had anything that's super successful and effective, or FDA approved for the treatment of these conditions. Having dupilumab approved for patients with prurigo nodularis is going to change how I treat patients, because now I have something that is FDA approved and has proven efficacy and safety and tolerability for my patients, as opposed to just kind of, you know, throwing the kitchen sink at them, you know, topical steroids, light treatments, you know, things that aren't super effective and not FDA approved.

Carrie Nagorka, Senior Editor: Do you see a lot of patients that are just very frustrated with this condition?

Spizuoco: Yes. All over our dermatology community and even in primary care and other specialties. We see tons of patients suffering from this condition, because it's extremely itchy and a lot of them affect their activities of daily living. They can't sleep, they're not concentrating at work, they are not concentrating in school. We see tons of patients suffering with this condition that haven't had good treatment that's effective and safe for them.

Nagorka: Understood! Is there anything else you want to add?

Spizuoco: Just that I'm really excited that this medication is now going to be approved for our patients suffering with prurigo nodularis. We've seen its efficacy in patients with atopic dermatitis and other conditions in the allergy immunology world. So, it is nice to see that we have something that is approved and is effective for our patients suffering from extreme itch and skin lesions.

Transcript edited for clarity


1. Study of Dupilumab for the Treatment of Patients with Prurigo Nodularis, Inadequately Controlled on Topical Prescription Therapies or When Those Therapies Are Not Advisable (PRIME2). ClinicalTrials.gov identifier: NCT04202679. Updated September 28, 2022. Accessed September 28, 2022.https://clinicaltrials.gov/ct2/show/NCT04202679?term=PRIME2&cond=Prurigo+Nodularis&draw=2&rank=1

2. Study of Dupilumab for the Treatment of Patients with Prurigo Nodularis, Inadequately Controlled on Topical Prescription Therapies or When Those Therapies Are Not Advisable (LIBERTY-PN PRIME). ClinicalTrials.gov identifier: NCT04183335. Updated February 17, 2022. Accessed September 28, 2022.https://clinicaltrials.gov/ct2/show/NCT04183335?term=PRIME%2C+dupilumab&draw=2&rank=1

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