Latest news with #Filsuvez
Belfast Telegraph
18-05-2025
- Health
- Belfast Telegraph
Cutting-edge medicines hoped to transform treatment of incurable skin condition
Debra, which supports 300 people living with epidermolysis bullosa (EB) in Ireland, said the entry of Filsuvez into the Irish market will ease the extreme pain endured by those with 'Butterfly Skin'. The disease is caused by the absence of proteins between the skin layers, making the skin ultra fragile and easy to wound. The charity insists that the expected introduction of the prescription medical gel before the end of the year could pave the way for gene therapy treatments, such as Vyjuvek. Sinead Hickey, head of research at Debra, said: 'Where Filsuvez is a promising start, as it can offer temporary pain relief, we hope it will mark the beginning for the treatment of rare disease in Ireland. 'Vyjuvek has the potential to provide life-changing wound healing for people living with Dystrophic EB, it has already proven to be very effective in the US.' The topical gel delivers new COL7A1 genes directly to skin wounds to promote wound healing. Ms Hickey said it does not have to be applied by a medical practitioner but can be done by a trained individual or family member. 'Unfortunately, Ireland is one of the slowest countries in Europe to move from recommendation to market and it could still be between seven and 12 years before we see Vyjuvek available to people here,' she said. Filsuvez, meanwhile, is applied to a sterile non-adhesive wound dressing or directly to the skin to ease the extreme pain of wounds caused by EB. Debra made submissions to the NCPE (National Centre for Pharmacoeconomics), which has recommended the HSE provides the gel once agreement is reached on pricing. A timeline has yet to be announced but Debra is optimistic a resolution will be found by the end of summer. The charity's chief executive, Jimmy Fearon, said its entry into the Irish market is a step in the right direction. 'The treatment for EB hasn't advanced much over time, so new treatments always bring hope,' he said. 'This is not a cure but it may reduce the equivalent of a bandage change every two weeks, providing some pain alleviation. 'What this primarily represents is hope, breaking through the glass ceiling would hopefully mean that others will follow. 'Debra and other EB charities around the world support and invest in important research but, ultimately, it's the pharmaceutical companies and venture capitalists that run the breakthrough.' Ireland is in the lowest quartile in Europe for introducing new drugs to the market, the chief executive said. 'It's an arduous process to bring a drug to market and this is a positive step,' added Mr Fearon. 'What we really need is faster progression from recommendation to market – time is of the essence for the 300 people in Ireland living in pain due to this condition.'
The Journal
18-05-2025
- Health
- The Journal
Cutting-edge medicines hoped to transform treatment of incurable skin condition EB
THE INTRODUCTION OF two new cutting-edge medicines are hoped to transform the treatment of a rare incurable skin condition, a charity has said. Debra, which supports 300 people living with epidermolysis bullosa (EB) in Ireland, said the entry of Filsuvez into the Irish market will ease the extreme pain endured by those with 'Butterfly Skin'. The disease is caused by the absence of proteins between the skin layers, making the skin ultra fragile and easy to wound. The charity insists that the expected introduction of the prescription medical gel before the end of the year could pave the way for gene therapy treatments, such as Vyjuvek. Sinead Hickey, head of research at Debra, said: 'Where Filsuvez is a promising start, as it can offer temporary pain relief, we hope it will mark the beginning for the treatment of rare disease in Ireland. 'Vyjuvek has the potential to provide life-changing wound healing for people living with Dystrophic EB, it has already proven to be very effective in the US.' Actor Colin Farrell with his friend Emma Fogarty, running in the Irish Life Dublin Marathon in Dublin in October, to raise money for people living with Epidermolysis Bullosa (EB), a rare genetic skin condition suffered by Ms Fogarty. Alamy Stock Photo Alamy Stock Photo The topical gel delivers new COL7A1 genes directly to skin wounds to promote wound healing. Ms Hickey said it does not have to be applied by a medical practitioner but can be done by a trained individual or family member. 'Unfortunately, Ireland is one of the slowest countries in Europe to move from recommendation to market and it could still be between seven and 12 years before we see Vyjuvek available to people here,' she said. Advertisement Filsuvez, meanwhile, is applied to a sterile non-adhesive wound dressing or directly to the skin to ease the extreme pain of wounds caused by EB. Debra made submissions to the NCPE (National Centre for Pharmacoeconomics), which has recommended the HSE provides the gel once agreement is reached on pricing. A timeline has yet to be announced but Debra is optimistic a resolution will be found by the end of summer. The charity's chief executive, Jimmy Fearon, said its entry into the Irish market is a step in the right direction. 'The treatment for EB hasn't advanced much over time, so new treatments always bring hope,' he said. 'This is not a cure but it may reduce the equivalent of a bandage change every two weeks, providing some pain alleviation. 'What this primarily represents is hope, breaking through the glass ceiling would hopefully mean that others will follow. 'Debra and other EB charities around the world support and invest in important research but, ultimately, it's the pharmaceutical companies and venture capitalists that run the breakthrough.' Ireland is in the lowest quartile in Europe for introducing new drugs to the market, the chief executive said. 'It's an arduous process to bring a drug to market and this is a positive step,' added Mr Fearon. 'What we really need is faster progression from recommendation to market – time is of the essence for the 300 people in Ireland living in pain due to this condition.'
Irish Daily Mirror
18-05-2025
- Health
- Irish Daily Mirror
Entry of new medicine into Irish market to ease pain of incurable skin condition
The introduction of two new cutting-edge medicines are hoped to transform the treatment of a rare incurable skin condition, a charity has said. Debra, which supports 300 people living with epidermolysis bullosa (EB) in Ireland, said the entry of Filsuvez into the Irish market will ease the extreme pain endured by those with 'Butterfly Skin'. The disease is caused by the absence of proteins between the skin layers, making the skin ultra fragile and easy to wound. The charity insists that the expected introduction of the prescription medical gel before the end of the year could pave the way for gene therapy treatments, such as Vyjuvek. Sinead Hickey, head of research at Debra, said: "Where Filsuvez is a promising start, as it can offer temporary pain relief, we hope it will mark the beginning for the treatment of rare disease in Ireland. "Vyjuvek has the potential to provide life-changing wound healing for people living with Dystrophic EB, it has already proven to be very effective in the US." The topical gel delivers new COL7A1 genes directly to skin wounds to promote wound healing. Ms Hickey said it does not have to be applied by a medical practitioner but can be done by a trained individual or family member. "Unfortunately, Ireland is one of the slowest countries in Europe to move from recommendation to market and it could still be between seven and 12 years before we see Vyjuvek available to people here," she said. Filsuvez, meanwhile, is applied to a sterile non-adhesive wound dressing or directly to the skin to ease the extreme pain of wounds caused by EB. Debra made submissions to the NCPE (National Centre for Pharmacoeconomics), which has recommended the HSE provides the gel once agreement is reached on pricing. A timeline has yet to be announced but Debra is optimistic a resolution will be found by the end of summer. The charity's chief executive, Jimmy Fearon, said its entry into the Irish market is a step in the right direction. "The treatment for EB hasn't advanced much over time, so new treatments always bring hope," he said. "This is not a cure but it may reduce the equivalent of a bandage change every two weeks, providing some pain alleviation. "What this primarily represents is hope, breaking through the glass ceiling would hopefully mean that others will follow. "Debra and other EB charities around the world support and invest in important research but, ultimately, it's the pharmaceutical companies and venture capitalists that run the breakthrough." Ireland is in the lowest quartile in Europe for introducing new drugs to the market, the chief executive said. "It's an arduous process to bring a drug to market and this is a positive step," added Mr Fearon. "What we really need is faster progression from recommendation to market – time is of the essence for the 300 people in Ireland living in pain due to this condition."
BreakingNews.ie
18-05-2025
- Health
- BreakingNews.ie
Cutting-edge medicines hoped to transform treatment of incurable skin condition
The introduction of two new cutting-edge medicines are hoped to transform the treatment of a rare incurable skin condition, a charity has said. Debra, which supports 300 people living with epidermolysis bullosa (EB) in Ireland, said the entry of Filsuvez into the Irish market will ease the extreme pain endured by those with 'Butterfly Skin'. Advertisement The disease is caused by the absence of proteins between the skin layers, making the skin ultra fragile and easy to wound. The charity insists that the expected introduction of the prescription medical gel before the end of the year could pave the way for gene therapy treatments, such as Vyjuvek. Sinead Hickey, head of research at Debra, said: 'Where Filsuvez is a promising start, as it can offer temporary pain relief, we hope it will mark the beginning for the treatment of rare disease in Ireland. 'Vyjuvek has the potential to provide life-changing wound healing for people living with Dystrophic EB, it has already proven to be very effective in the US.' Advertisement Sinead Hickey, head of research at Debra, says Filsuvez is a promising start. Photo: Alejandra Livschitz/Debra The topical gel delivers new COL7A1 genes directly to skin wounds to promote wound healing. Ms Hickey said it does not have to be applied by a medical practitioner but can be done by a trained individual or family member. 'Unfortunately, Ireland is one of the slowest countries in Europe to move from recommendation to market and it could still be between seven and 12 years before we see Vyjuvek available to people here,' she said. Filsuvez, meanwhile, is applied to a sterile non-adhesive wound dressing or directly to the skin to ease the extreme pain of wounds caused by EB. Advertisement Debra made submissions to the NCPE (National Centre for Pharmacoeconomics), which has recommended the HSE provides the gel once agreement is reached on pricing. A timeline has yet to be announced but Debra is optimistic a resolution will be found by the end of summer. The charity's chief executive, Jimmy Fearon, said its entry into the Irish market is a step in the right direction. 'The treatment for EB hasn't advanced much over time, so new treatments always bring hope,' he said. Advertisement 'This is not a cure but it may reduce the equivalent of a bandage change every two weeks, providing some pain alleviation. 'What this primarily represents is hope, breaking through the glass ceiling would hopefully mean that others will follow. 'Debra and other EB charities around the world support and invest in important research but, ultimately, it's the pharmaceutical companies and venture capitalists that run the breakthrough.' Ireland Gel therapy to treat 'butterfly skin' condition we... Read More Ireland is in the lowest quartile in Europe for introducing new drugs to the market, the chief executive said. Advertisement 'It's an arduous process to bring a drug to market and this is a positive step,' added Mr Fearon. 'What we really need is faster progression from recommendation to market – time is of the essence for the 300 people in Ireland living in pain due to this condition.'
Epoch Times
29-04-2025
- Health
- Epoch Times
FDA Approves First Cell-Based Treatment for Rare Skin Disorder
The Food and Drug Administration (FDA) has approved Zevaskyn, a gene therapy for a rare skin disorder, the company that makes the product said on April 29. Regulators approved Zevaskyn for adults and children with recessive dystrophic epidermolysis bullosa, a disorder that leaves skin fragile and prone to blistering. Severe cases of the disorder can result in loss of vision and other serious medical issues, according to the National Library of Medicine. Recessive dystrophic epidermolysis bullosa has no cure. Zevaskyn is the first cell-based gene therapy to receive approval for the condition. Abeona Therapeutics, which makes the therapy, said it only requires one application. 'Through a single surgical application, Zevaskyn can now offer people with [the condition] the opportunity for wound healing and pain reduction in even the most severe wounds,' Vish Seshadri, Abeona's CEO, Related Stories 10/28/2024 4/28/2025 Seshadri thanked participants in the company's clinical studies, including a phase 3 trial that showed people who received the therapy experienced statistically significant improvement in healing, compared with a control group that received the standard of care. Adverse events included itching. 'Zevaskyn was well-tolerated and efficacious in clinical studies, providing clinically meaningful improvements in wound healing, pain reduction, and other associated symptoms,' Dr. Jean Tang, a professor of dermatology who was the trial's principal investigator, said in a statement. Zevaskyn involves taking a patient's skin cells and genetically modifying the cells to produce collagen. Up to 12 of the resulting cellular sheets are then surgically applied to a patient's wounds. The FDA did not return a request for comment. Brett Kopelan, the executive director of Debra of America, which advocates for people with epidermolysis bullosa, expressed support for Zevaskyn, saying in a statement released by Abeona that the therapy 'can significantly increase the quality of life of patients.' Abeona said it expects Zevaskyn to be available starting in the third quarter of 2025. Patients seeking the therapy can receive it through Zevaskyn-qualified treatment centers. About 3.3 per million people are affected by recessive and dominant dystrophic epidermolysis bullosa, Two treatments are currently available. The Food and Drug Administration approved Vyjuvek, a gene therapy from Krystal Biotech, in 2023. The gel is applied to wounds regularly, typically once a week. Filsuvez, also approved in 2023, and made by Chiesi Global Rare Diseases, can also be used. The gel, which contains birch bark, is also applied to wounds.
