NICE recommends Amryt’s Filsuvez treatment for epidermolysis bullosa

2023-08-21

临床3期上市批准临床结果

NICE recommends Amryt’s Filsuvez treatment for epidermolysis bullosa

Preview

来源: PMLiVE

The National Institute for Health and Care Excellence (NICE) has issued final draft guidance recommending Amryt Pharmaceuticals’ Filsuvez (birch bark extract) for treating skin wounds associated with dystrophic and junctional epidermolysis bullosa (EB).

Affecting around 500,000 people worldwide, EB is a rare inherited skin disorder that causes the skin to become fragile, causing blisters, tears and the loss of skin segments.

NICE’s decision marks the first time the institute has recommended an EB treatment, with around 670 patients in England expected to benefit from Filsuvez.

Helen Knight, director of health technology assessment at NICE, said: "There are substantial treatment requirements to manage [EB] symptoms. These include daily cleaning of wounds and dressing changes that can often total 37 hours a week and which themselves can cause substantial pain."

The recommendation follows positive results from the phase 3 birch bark extract clinical trial, EASE, which found that the treatment led to quicker wound healing in patients with dystrophic and junctional EB and had potential to reduce the amount of skin affected.

The EASE trial was the largest phase 3 randomised control trial to examine the efficacy and safety of Amryt’s Filsuvez gel/Oleogel-S10 in comparison to the control gel for EB.

Patients with EB from the EASE double-blind phase who received the treatment experienced a reduction in overall wound burdens, a reduced frequency of dressing changes, and were well tolerated, with a similar safety profile to control gel.

Dr Joe Wiley, chief executive of Amryt Pharma, commented on the EASE trial results, stating that they represented an "important advancement for patients and families living with this rare and distressing disorder".

Knight added: "[Filsuvez] has the potential to improve the quality of life for people with EB and their carers and help free up time for other activities" after receiving "valuable insight" from patients' experiences with EB from organisations including DEBRA and Genetic Alliance UK.

In June 2022, the European Commission approved Filsuvez in the EU for patients aged six months and older for partial-thickness wounds associated with dystrophic and junctional EB.

更多内容，请访问原始网站

文中所述内容并不反映新药情报库及其所属公司任何意见及观点，如有版权侵扰或错误之处，请及时联系我们，我们会在24小时内配合处理。

机构

Amryt AG