Christophe Piketty, MD, PhD: Nemolizumab's Unique Mechanism of Action and Next Steps Globally

Galderma’s nemolizumab (Nemluvio) recently received approval from the European Commission for the treatment of moderate to severe atopic dermatitis (AD) in patients 12 years and older, as well as moderate to severe prurigo nodularis (PN) in adults.¹ The therapy has also been authorized for the same indications in the UK and Switzerland.²

Dermatology Times spoke with Christophe Piketty, MD, PhD, a dermatologist and the global program head at Galderma R&D, to discuss the unique mechanism of action of nemolizumab and the next steps for global approval.

Nemluvio and IL-31: A Novel Mechanism of Action

Piketty began by highlighting the significance of Nemluvio's unique mechanism of action. While other biologics typically target IL-13 or IL-4 for conditions like AD, nemolizumab targets the IL-31 pathway, a cytokine pathway that plays a central role in these diseases.

The importance of this distinction lies in the significant therapeutic potential that targeting IL-31 offers, as it directly affects skin inflammation, bio disruption, and even fibrosis.

"We know that IL-31, of course, is the main driver for itch,” Piketty remarked, underscoring how this cytokine influences the pathological processes that lead to itching in AD and PN. "Nemluvio is markedly improving itch."

Addressing Skin Inflammation and Fibrosis

Piketty continued by elaborating on how nemolizumab's impact extends beyond just alleviating itch. He highlighted recent data demonstrating how IL-31 targeting also addresses skin inflammation in both AD and PN. For instance, in AD, the biologic helps to improve biodisruption, a key feature of the disease's pathophysiology.

"Targeting IL-31 could improve the biodisruption, which is a key feature of the pathophysiology of atopic dermatitis," Piketty explained.

Additionally, PN, which is associated with significant tissue remodeling and fibrosis, has shown significant improvements with nemolizumab treatment.

"We know that there is a lot of data now demonstrating that targeting IL-31 could improve also fibrosis," Piketty said. This antifibrotic effect explains the quick improvement of thick lesions observed in patients treated with nemolizumab

Approvals and Global Expansion

The approvals in the European Union, UK, and Switzerland follow nemolizumab's approval in the US last year.

"The submission process is ongoing at the moment. We have received the approval in the US last year for both AD and PN," Piketty said. "We have received a formal approval in Europe for both indications."

The drug is awaiting approval in Australia, Singapore, and several other countries. Additionally, ongoing submissions are happening in South Korea and Brazil, with more submissions planned for the coming months.

"It’s moving fast, I think, and soon we will have a lot of countries where the review will be approved," Piketty said. He expressed confidence that this rapid expansion will make a significant difference for patients suffering from AD and PN globally.

Treatment Regimen: Convenience for Patients

One of the standout features of nemolizumab is its convenient treatment regimen. According to Piketty, the biologic allows for injections every 4 weeks, which is notably less frequent than other biologics on the market.

For patients who respond well to treatment, the regimen becomes even more convenient. After reaching specific response markers such as EASI75 or IGA response at week 16, patients can switch to an even less frequent injection schedule.

"When using Nemluvio in combination with topical corticosteroids or topical calcineurin inhibitors, we have demonstrated that for patients responding, those patients could move to an even more convenient regimen," he explained.

Patients who achieve these milestones could reduce their injection frequency to once every 2 months, offering a substantial improvement in treatment convenience.

"I spent a lot of time on the development of this drug, from the beginning actually, in 2016," Piketty shared. "It’s quite a long journey, but now I’m pretty happy to see that the product is available for patients."

References

1. Galderma’s Nemluvio (nemolizumab) approved in the European Union for moderate-to-severe atopic dermatitis and prurigo nodularis. News release. February 14, 2025. Accessed February 25, 2025. https://www.galderma.com/news/galdermas-nemluvior-nemolizumab-approved-european-union-moderate-severe-atopic-dermatitis-and
2. Galderma’s Nemluvio (nemolizumab) granted marketing authorization in the United Kingdom and Switzerland for moderate-to-severe atopic dermatitis and prurigo nodularis. News release. February 18, 2025. Accessed February 25, 2025. https://www.galderma.com/news/galdermas-nemluvior-nemolizumab-granted-marketing-authorization-united-kingdom-and-0