Regulatory Approval of Nemluvio (nemolizumab) for Atopic Dermatitis and Prurigo Nodularis in Canada
On 12 January 2026, the Swiss specialty‑pharmaceutical company Galderma Group AG received regulatory approval from Health Canada for its investigational monoclonal antibody Nemluvio (nemolizumab). The decision expands the drug’s therapeutic indication to include patients suffering from atopic dermatitis (AD) and prurigo nodularis (PN), two chronic dermatologic conditions characterized by intense pruritus and skin inflammation.
Scientific Rationale
Nemolizumab is a humanized IgG1κ monoclonal antibody that selectively blocks the interleukin‑31 receptor A (IL‑31RA) subunit. IL‑31 is a cytokine produced by activated T cells that plays a pivotal role in pruritus and cutaneous inflammation. By inhibiting IL‑31 signaling, nemolizumab reduces itch sensation, decreases inflammatory cell recruitment, and promotes barrier repair in keratinocytes. Preclinical studies in murine models of dermatitis demonstrated significant attenuation of scratching behavior and epidermal hyperplasia following single subcutaneous administrations of nemolizumab.
Clinical Development Program
The approval is grounded on two phase III, randomized, double‑blind, placebo‑controlled trials—Phase III‑AD and Phase III‑PN—each enrolling 480 patients. Key efficacy endpoints were the Eczema Area and Severity Index (EASI) for AD and the Prurigo Nodularis Severity Score (PNSS) for PN, with primary endpoints measured at week 12.
| Trial | Population | Primary Endpoint | Result |
|---|---|---|---|
| Phase III‑AD | 480 adults with moderate‑to‑severe AD | ≥ 75 % reduction in EASI | 53 % of nemolizumab recipients vs. 22 % placebo (p < 0.001) |
| Phase III‑PN | 480 adults with chronic PN | ≥ 30 % reduction in PNSS | 46 % of nemolizumab recipients vs. 19 % placebo (p < 0.001) |
Secondary outcomes, including Itch Numerical Rating Scale (NRS) and Dermatology Life Quality Index (DLQI), consistently favored nemolizumab, with clinically meaningful improvements sustained through week 24. Safety data showed a low incidence of infusion reactions (1.2 %) and no significant differences in serious adverse events between groups.
Regulatory Pathway and Approval Context
Health Canada’s decision follows a BLA (Biologics License Application) submission that incorporated all pivotal data, pharmacokinetic analyses, and a robust risk‑management plan. The agency cited the drug’s favorable benefit‑risk profile and the unmet medical need for targeted anti‑pruritic therapies in AD and PN. The approval aligns with the Canadian PDPS (Patient‑Driven Health Solutions) framework, which emphasizes timely access to innovative biologics for conditions lacking effective treatments.
Market Implications
The Canadian clearance augments Galderma’s North American portfolio, providing a new revenue stream in a market where AD and PN collectively generate over $5 billion in annual prescription spending. Although Galderma’s Swiss‑market shares dipped slightly following the announcement, the broader index remained near flat due to prevailing geopolitical tensions and uncertainties in monetary policy.
Strategically, the approval positions Galderma to pursue co‑commercialization agreements with U.S. partners and to accelerate a global launch strategy. The company’s existing pipeline—encompassing a portfolio of dermatologic biologics, including a biosimilar to dupilumab—supports its broader objective of becoming a leading provider of precision‑medicine solutions for chronic skin diseases.
Conclusion
The Canadian approval of Nemluvio for atopic dermatitis and prurigo nodularis represents a significant milestone for Galderma and the specialty‑pharmaceutical sector. The evidence base, grounded in robust phase III data, demonstrates that IL‑31RA blockade offers a novel therapeutic modality that directly targets the pruritic pathway, addressing a critical gap in current dermatologic care. While the market response remains cautious, the regulatory success is a clear indication of the growing acceptance of biologic therapies in dermatology and underscores the potential for further expansion into other atopic and inflammatory skin disorders.
