Gil Yosipovitch, MD: Next Steps Following FDA Approval of Nemolizumab for Prurigo Nodularis

Following the August 13 announcement of the US Food and Drug Administration (FDA) approval of nemolizumab (Nemluvio) for adult patients with prurigo nodularis, the HCPLive editorial team spoke to an investigator from the OLYMPIA trial system that led up to this approval.^1,2

Gil Yosipovitch, MD, professor of dermatology for the Miller School of Medicine at the University of Miami, discussed the significance of the approval for patients with prurigo nodularis, a chronic neuroimmune skin disease characterized by intense itch and impacting close to 181,000 patients in the US. In this interview segment, he was asked to discuss any challenges or unexpected outcomes encountered during the OLYMPIA trials.

“I'd love to have a biomarker that I could tell you, ‘This is a patient who will respond better to nemolizumab versus dupilumab or vice versa,’” Yosipovitch said. “We don't have that yet, but I feel that all the patients with prurigo nodularis at this stage are going to be a good candidate for this type of drug. As I mentioned, I'm more excited about this drug’s opening in the field.”

Yosipovitch noted that dupilumab was the first to open the field of the world of itch treatment, given that it changed so much for many patients in terms of itch and quality of life. He commented that he believes that nemolizumab will follow this path in terms of its potential to be effective with chronic pruritus.

Later, Yosipovitch was asked about what clinicians should bear in mind following the OLYMPIA trials and the FDA approval of nemolizumab.

“I don't represent a company here, but I would say that I always, with dupilumab, tried off-label use for other indications,” Yosipovitch said. “And I think that will possibly lead to having this drug available for other conditions. This is one of the advantages when you have such a drug. I'm quite sure of it. In the next 5 years we will know whether nemolizumab works for other conditions.”

To find out more about the FDA approval and Yosipovitch’s clinical trial conclusions, view the full interview above.

The quotes included in this summary were edited for 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. ^{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.}
2. ^{Smith T. What the FDA Approval of Nemolizumab Means for Prurigo Nodularis, with Gil Yosipovitch, MD. August 17, 2024. https://www.hcplive.com/view/what-the-fda-approval-nemolizumab-means-for-prurigo-nodularis-gil-yosipovitch-md. Date accessed: August 19, 2024.}