Summary
Health Canada authorized Nemluvio®, a first-in-class biologic for eczema and prurigo nodularis that specifically targets the biological cause of chronic itch. While national funding reviews are still underway, this approval provides a vital new option for patients who haven't found relief with standard creams.
A new era in dermatological care has arrived for Canadians suffering from chronic, debilitating itch. Health Canada authorized Nemluvio® (nemolizumab) for the treatment of moderate-to-severe atopic dermatitis (eczema) in patients aged 12 and older, as well as prurigo nodularis in adults.
Nemluvio® is a first-in-class biologic that specifically targets the neuro-immune pathway responsible for itch, providing a much-needed alternative for patients whose conditions are not adequately controlled by topical therapies.
Targeting the “Itch Cytokine”
Unlike traditional eczema treatments that focus primarily on skin inflammation, Nemluvio® is the first monoclonal antibody designed to block interleukin-31 (IL-31). Often referred to by scientists as the “itch cytokine,” IL-31 sends signals directly to the nervous system to trigger the urge to scratch.
By blocking this signal, Nemluvio® addresses the most burdensome symptom of these conditions: the relentless itch that leads to sleep deprivation, skin damage, and significant mental health strain.
“Nemolizumab’s ability to rapidly target itch makes it an exciting and much-needed advancement, offering patients relief where they need it most,” said Dr. Chih-ho Hong, Board-Certified Dermatologist, MD, FRCPC, Surrey, BC.
Proven Clinical Success
The Health Canada authorization was based on robust data from two major Phase III clinical programs:
- ARCADIA 1 & 2 (Atopic Dermatitis): These trials demonstrated that Nemluvio, administered every four weeks, significantly improved skin lesions and reduced itch in adults and adolescents.
- OLYMPIA 1 & 2 (Prurigo Nodularis): This program, the largest of its kind for this condition, showed that the treatment significantly improved itch and cleared skin nodules compared to a placebo.
Status in Canada: The Road to Access
While Nemluvio® is now authorized for sale in Canada, its widespread availability under public insurance is still in progress.
- Reimbursement Review: The drug is currently undergoing a cost-effectiveness review by Canada’s Drug Agency (CDA-AMC). This national review is a required step before the drug can be listed on federal, provincial, and territorial public drug plans.
- Cost & Funding: Because the review is ongoing, an official, widely available list price for patient use has not yet been finalized or publicly released. Until funding decisions are made by the provinces, Nemluvio® is not yet a regular benefit under most public insurance plans.
- Patient Support: Historically, specialty biologics are supported by manufacturer-led patient assistance programs. These programs often help patients navigate early access and insurance coverage during the reimbursement review phase.
Is It Right For You?
Nemluvio® is intended for those whose disease is not adequately controlled with topical prescription therapies. Because it is an injectable medication given once every four weeks, it offers a convenient schedule for those looking to move away from daily creams or more frequent injections.
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