What the FDA Approval of Nemolizumab Means for Prurigo Nodularis, with Gil Yosipovitch, MD

On August 13, the US Food and Drug Administration (FDA) approval of nemolizumab (Nemluvio) for adults with prurigo nodularis was announced. Prurigo nodularis is a chronic neuroimmune skin disease affecting around 181,000 individuals in the US and is a condition characterized by intense itch.¹

Nemolizumab is administered to patients subcutaneously using a pre-filled pen. The approval of this medication follows the positive phase 3 findings from the OLYMPIA clinical trials.² One of the investigators—Gil Yosipovitch, MD, professor of dermatology for the Miller School of Medicine at the University of Miami—spoke with HCPLive about the approval’s significance.

“It is indeed exciting news, because interleukin-31 has been coined the ‘itchy cytokine’ for a lot of reasons,” Yosipovitch said. “This cytokine has a role in almost every type of chronic itch, not just in atopic eczema…A hallmark of (prurigo nodularis) is horrible chronic itch and patients are miserable. Indeed, this drug works extremely well for these patients, and it's a very important aspect of improving a patient's life.”

The OLYMPIA trial program that Yosipovitch was a part of evaluated nemolizumab’s safety and efficacy among 500 patients treated every 4 weeks. The study met both the primary and secondary endpoints, with the medication resulting in clinically meaningful and significant itch and skin nodule improvements by the 16-week mark.²

The study’s primary end points had been a reduction in itch of ≥4 points on the Peak Pruritus Numerical Rating Scale (PP-NRS) as well as an Investigator's Global Assessment (IGA) response and a reduction from the point of baseline to the 16-week mark of ≥2 points. Yosipovitch noted the drug’s success and the speed at which his team noted these results.

“It works very fast, and that's important for patients because patients want fast results,” Yosipovitch explained. “Rapidly, you could see the itch go down. That's one issue. Second, which interests all dermatologists, is whether it has side effects and it has a good safety profile. That's extremely important, too. And third, it not just improves the itch, but the lesions have gone.”

For additional information on the approval’s significance, view the full interview segment above.

The quotes in this summary were edited for the purposes of clarity. Yosipovitch has conducted clinical trials for or received research funds and/or honoraria for serving on the scientific advisory boards of: AbbVie, Arcutis, Cara Therapeutics, Celldex Therapeutics, CeraVe, Eli Lilly and Company, Escient Pharmaceuticals, Galderma, Kiniksa Pharmaceuticals, LEO Pharma, Maruho, Novartis, Pfizer, Pierre Fabre, Regeneron, Sanofi and Vifor Pharma.

References

1. ^{Smith T. FDA Approves Nemolizumab for Treatment of Prurigo Nodularis. HCPLive. August 13, 2024. https://www.hcplive.com/view/fda-approves-nemolizumab-treatment-prurigo-nodularis. Date accessed: August 16, 2024.}
2. ^{Kwatra SG, Yosipovitch G, Ständer S, et al; OLYMPIA 2 Investigators. Phase 3 Trial of Nemolizumab in Patients with Prurigo Nodularis. N Engl J Med. 2023 Oct 26;389(17):1579-1589. doi: 10.1056/NEJMoa2301333. PMID: 37888917.}