Pharmaceutical Market Europe • September 2026 • 10
NEWS
NICE recommends axunio’s Axhidrox for severe excessive sweating
NICE has recommended axunio UK’s glycopyrronium bromide (GPB) cream for routine NHS use in England for adults with severe primary axillary hyperhidrosis (PAHH). GPB cream is designed to block the signalling pathway that activates the sweat glands, helping to reduce excessive sweating.
Around 75,000 people in England may be eligible for treatment. In the phase 3b study, median total sweat production was significantly reduced by 65.6% following 12 weeks of treatment with GPB 1% cream compared with baseline.
Severe PAHH is characterised by excessive sweating beyond what is required for normal temperature regulation and it can have a greater impact on a patient’s quality of life than other skin conditions such as atopic eczema, acne, psoriasis or rosacea.
Hyperhidrosis is estimated to affect 1-5% of the population and can have a substantial impact on daily activities, social interactions, emotional well-being and quality of life. Despite this burden, the condition remains under-recognised and under-diagnosed.
This recommendation marks an important step forward in the treatment of severe PAHH as it represents the first time NICE has evaluated and recommended a treatment option specifically for hyperhidrosis.
BriaCell advances vaccine candidate for skin cancer
BriaCell Therapeutics’ Bria-MEL+, its personalised whole cell melanoma (skin cancer) immunotherapy vaccine candidate, has achieved a key genetic engineering milestone, advancing the programme towards clinical development.
Bria-MEL+ is a cell-based therapeutic cancer vaccine designed to harness a patient’s own immune system to combat melanoma. The programme is personalised yet ‘off the shelf (OTS)’: a simple patient saliva test will determine which of the several premanufactured treatment cell lines will be selected for personalised treatment, avoiding the need to manufacture a unique product for each individual patient.
Bria-MEL+ is designed to activate multiple components of the immune system, including innate and adaptive immune responses, to target and destroy melanoma cells. The programme is derived from BriaCell’s Bria-OTS+ cellular immunotherapy platform and is being developed using pre-manufactured cell lines selected through patient HLA matching.
The American Cancer Society estimates that approximately 112,000 new cases of melanomas will be diagnosed in the US in 2026, including about 65,400 in men and 46,600 in women. Despite major advances in treatment, melanoma remains a significant unmet medical need, with over 8,500 deaths from melanoma expected in the US in 2026.
Pfizer announces phase 3 results for non-segmental vitiligo treatment
Pfizer has announced positive topline results from two phase 3 trials evaluating the efficacy and safety of Litfulo once daily in patients with both active and stable non-segmental vitiligo (NSV) and who had a broad range of disease severity.
The studies showed significant, clinically meaningful improvements for both face and body. Based on these results, Pfizer intends to submit global regulatory filings for Litfulo as a potential new oral systemic therapy for NSV for adults.
NSV is a chronic autoimmune disease in which the immune system attacks melanin-producing cells, leading to a loss of pigment and resulting in white macules and patches on the skin/hair over time. NSV can appear at any age and in all skin types, causing depigmentation anywhere on the skin, often affecting highly visible areas such as the face, neck and hands.
While vitiligo is frequently treated as a cosmetic condition, it is a serious autoimmune disease that can have a considerable impact on patients’ lives well beyond the physical symptoms. Because NSV is a chronic disease, systemic treatment options may be needed to help patients restore skin pigmentation and maintain repigmentation over time.