We are delighted to hear that Filsuvez®, the gel developed by Amryt Pharma as a treatment to promote the healing of partial thickness wounds associated with dystrophic EB (DEB) and junctional EB (JEB) has now been approved for use in the UK by the National Institute for Health Care and Excellence (NICE).

This follows on from last year’s approval for Filsuvez® to be used in Great Britain by the Medical Healthcare & Products Regulatory Agency (MHRA) and means that the UK will now be the first country in the world to be able to offer Filsuvez® as an approved drug treatment for patients with DEB and JEB.

Following the approval from NICE we can expect to see Filsuvez® available via prescription for UK DEB and JEB patients aged 6 months+ through the national NHS EB specialist centres before the end of 2023.

We would like to pass on our congratulations and thanks to Amryt Pharma for successfully securing NICE approval for Filsuvez®. We would also like to thank the DEBRA members who provided powerful patient testimony on the behalf of the EB community in support of the NICE application.

DEBRA has supported Amryt Pharma throughout the year-long NICE approval process by providing the patient voice input, we have also signposted members to an on-line survey to gather more information on the carer requirements for patients with DEB and JEB.

Commenting on the news, DEBRA UK CEO Tony Byrne said:

This is very positive news, people living with all types of EB desperately need treatments that can positively impact their symptoms and improve their overall quality of life so it is hugely encouraging that the first approved drug treatment for patients with DEB and JEB could start being prescribed to patients here in the UK by the end of the year. On the behalf of the EB community, I would like to thank Amryt Pharma and NICE for facilitating this approval, and all our members who supported the application. There is still much work to do to ensure approved drug treatments are available for all types of EB, but this is a promising first step. It provides hope today for patients with DEB and JEB and will hopefully be a catalyst for future drug treatments for the wider EB community.  

To find out more about Filsuvez®, please read the announcement from NICE.

You can also take a look at our Filsuvez® FAQs.