Dermatology specialist Galderma (SWX:GALD) announced on Thursday that the UK's National Institute for Health and Care Excellence has issued final draft guidance recommending nemolizumab for routine funding by the National Health Service in England and Wales for moderate-to-severe atopic dermatitis.
This recommendation follows the recent marketing authorisation of nemolizumab in the UK by the Medicines and Healthcare products Regulatory Agency. The approval is supported by results from the phase III ARCADIA clinical programme, which demonstrated significant clinical improvement in itch, sleep disturbance, and skin lesions.
Nemolizumab is a monoclonal antibody that targets IL-31 receptor alpha, a neuroimmune cytokine pathway implicated in the itch and inflammation of atopic dermatitis. It is the first approved biologic for atopic dermatitis with four-week dosing intervals from treatment initiation.
The condition affects approximately 1.6 million individuals in the UK and is often associated with mental health and autoimmune comorbidities. Nemolizumab is indicated for patients aged 12 years and older who weigh at least 30 kg and are eligible for systemic therapy.
Galderma acquired global development and marketing rights (excluding Japan) for nemolizumab from Chugai Pharmaceutical Co Ltd in 2016.
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