Filsuvez (AP101) / Chiesi - LARVOL DELTA

SG12 A rare case of perianal granular cell tumour in a patient with localized recessive dystrophic epidermolysis bullosa. (PubMed, Br J Dermatol) - "The wound site was left open to promote healing; however, this was complicated by concomitant RDEB resulting in persisting well-demarcated ulceration unresponsive to topical Oleogel-S10, mupirocin 2% and Trimovate®. Botulinum toxin injections, topical glyceryl trinitrate and diltiazem are now being considered as the next step for this patient, with the aim of encouraging skin healing by relaxing the anal sphincter muscle...Additionally, this case presents the importance of tailored examinations under anaesthesia to facilitate perianal diagnoses in patients with EB, where skin fragility and pain limit the feasibility of routine examination methods. This case joins the existing literature that reports the challenges of wound healing in EB postoperatively, but importantly suggests that future management of other, nonsurgical perianal wounds in EB could also utilize similar techniques involving therapeutic anal sphincter muscle relaxation."

Journal • Anesthesia • Oncology • Pain • CD68

Epidermal regeneration in recessive dystrophic epidermolysis bullosa following treatment with birch bark extract: insights from line field confocal optical coherence tomography imaging (EADV 2025) - "LC-OCT imaging confirmed early full epidermal regeneration, including a fully developed stratum corneum, in patients with RDEB following the topical application of birch bark extract as soon as after a few days. In addition, it allowed a timely non-invasive temporal evaluation of changes during progressive wound re-epithelialization. This in vivo model demonstrated that LC-OCT enables non-invasive, real-time tracking of wound healing dynamics in RDEB, supporting its potential for broader application in non-invasive dermatological research."

Dermatology • Pruritus

Methodological Concerns in the EASE Study of Oleogel-S10 for Epidermolysis Bullosa: reply from authors. (PubMed, Br J Dermatol) - No abstract available

Journal

Methodological Concerns in the EASE Study of Oleogel-S10 for Epidermolysis Bullosa. (PubMed, Br J Dermatol) - No abstract available

Journal

Reduction in Dressing Change Burden in Patients With Epidermolysis Bullosa-Impact of Oleogel-S10. (PubMed, J Dermatol) - P3 | "Estimated dressing costs reduced by 59%, from $63.4 k to $25.9 k per patient over 27 months. Oleogel-S10 significantly reduced dressing frequency and time burden, with potential to ease the intensive demands of EB wound care."

Clinical • Journal • Genetic Disorders • Mood Disorders • Pain

Real-world case series: Birch triterpenes gel efficacy in 2 patients with junctional epidermolysis bullosa. (PubMed, JAAD Case Rep) - No abstract available

Journal • Real-world evidence

REVIVE: A Study to Learn About the Safety and Efficacy of the Drug Oleogel-S10 in Japanese Patients With Epidermolysis Bullosa (clinicaltrials.gov) - P3 | N=6 | Recruiting | Sponsor: Chiesi Farmaceutici S.p.A. | Not yet recruiting ➔ Recruiting

Enrollment open • Dermatology • Genetic Disorders • Rheumatology

Mediterranean Basin Erica Species: Traditional Uses, Phytochemistry and Pharmacological Properties. (PubMed, Molecules) - "Filsuvez®, comprising pentacyclic triterpenes from birch bark, has clinical approval for the treatment of partial thickness wounds associated with dystrophic and junctional epidermolysis bullosa. The undoubted reservoir of pentacyclic triterpenes and flavonoid glycosides in Mediterranean Erica species warrants further comprehensive mechanistic studies, toxicological evaluations and clinical validation."

Journal • Review • Gastrointestinal Disorder • Pain

Towards Extracellular Vesicles in the Treatment of Epidermolysis Bullosa. (PubMed, Bioengineering (Basel)) - "Current treatments focus on symptomatic relief through wound care and pain management, with recent FDA approvals of Vyjuvek and Filsuvez providing new but limited therapeutic options...However, challenges remain, including standardization of EV production, scalability, and ensuring consistent therapeutic potency. Despite these hurdles, EV-based therapies represent a transformative step toward addressing the complex pathology of EB, with the potential to improve wound healing, reduce fibrosis, and enhance patient quality of life."

Journal • Review • Dermatology • Fibrosis • Graft versus Host Disease • Immunology • Oncology • Pain

REVIVE: A Study to Learn About the Safety and Efficacy of the Drug Oleogel-S10 in Japanese Patients With Epidermolysis Bullosa (clinicaltrials.gov) - P3 | N=6 | Not yet recruiting | Sponsor: Chiesi Farmaceutici S.p.A.

New P3 trial • Dermatology • Genetic Disorders • Rheumatology

FOSteR: A Study to Assess the Incidence of Skin Cancers in Patients With Epidermolysis Bullosa Receiving Filsuvez (clinicaltrials.gov) - P=N/A | N=580 | Recruiting | Sponsor: Amryt Pharma | Not yet recruiting ➔ Recruiting

Enrollment open • Genetic Disorders • Oncology • Skin Cancer

Long-term safety and efficacy of Oleogel-S10 (birch bark extract) in epidermolysis bullosa: 24-month results from the Phase III EASE Study. (PubMed, Br J Dermatol) - "These data support an encouraging long-term safety profile of Oleogel-S10, and a sustained reduction in wound burden over at least 24 months of Oleogel-S10 treatment."

Journal • P3 data • Genetic Disorders • Infectious Disease • Pain

From Plant to Patient: A Historical Perspective and Review of Selected Medicinal Plants in Dermatology. (PubMed, JID Innov) - "This review covers various plant-derived therapeutics (polyphenon E [sincatechins], psoralen, salicylic acid, anthralin, podophyllotoxin, and Filsuvez [birch triterpenes, oleogel-S10]) that have demonstrated scientific evidence of clinical efficacy for dermatologic disorders. The discovery, composition, history of use, and current uses in dermatology are summarized for each botanical ingredient."

Journal • Review • Acne Vulgaris • Dermatology • Immunology • Psoriasis • Vitiligo

Effect of Triterpene Extract on Skin Cohesion in Epidermolysis Bullosa (EADV 2024) - "Collectively, our data suggest potential context-dependent skin stabilizing properties of TE in JEB and DEB. TE in JEB evokes, basal localization of cell-matrix adhesion complexes adhesion strength, which may account for the improved epidermal to dermal cohesion observed in TE-treated JEB HSEs. This finding, coupled with other pre- clinical studies, further supports the clinically demonstrated wound healing properties of Oleogel-S10 specifically in JEB and DEB."

KRT14 • LORICRIN

Effect of Triterpene Extract on Skin Cohesion in Epidermolysis Bullosa (EADV 2024) - "Collectively, our data suggest potential context-dependent skin stabilizing properties of TE in JEB and DEB. TE in JEB evokes, basal localization of cell-matrix adhesion complexes adhesion strength, which may account for the improved epidermal to dermal cohesion observed in TE-treated JEB HSEs. This finding, coupled with other pre- clinical studies, further supports the clinically demonstrated wound healing properties of Oleogel-S10 specifically in JEB and DEB."

Dermatology • KRT14 • LORICRIN

A Study of Oleogel-S10 Gel for the Treatment of Radiation Dermatitis in People With Breast Cancer (clinicaltrials.gov) - P2 | N=18 | Completed | Sponsor: Memorial Sloan Kettering Cancer Center | Recruiting ➔ Completed | N=50 ➔ 18 | Trial completion date: Dec 2026 ➔ Aug 2024 | Trial primary completion date: Dec 2026 ➔ Aug 2024

Enrollment change • Trial completion • Trial completion date • Trial primary completion date • Breast Cancer • Contact Dermatitis • Dermatitis • Dermatology • Immunology • Oncology • Solid Tumor

FOSteR: A Study to Assess the Incidence of Skin Cancers in Patients With Epidermolysis Bullosa Receiving Filsuvez (clinicaltrials.gov) - P=N/A | N=580 | Not yet recruiting | Sponsor: Amryt Pharma

New trial • Genetic Disorders • Oncology • Skin Cancer

Oleogel-S10 reduces dressing changes burden and associated costs in patients with epidermolysis bullosa (SID 2024) - No abstract available

Clinical

Oleogel-S10 in Dystrophic Epidermolysis Bullosa: A Case Series Evaluating the Impact on Wound Burden Over Two Years. (PubMed, Adv Ther) - "Two deaths during treatment interruption were reported and was not considered related to Oleogel-S10. This study supports the effectiveness of Oleogel-S10 in a real-world scenario in a country with scarce resources for the treatment of EB."

Journal

A Structured Expert Elicitation Exercise Conducted With UK Clinicians to Inform and Validate Inputs for a Cost-Effectiveness Analysis of FILSUVEZ® Gel (Birch Bark Extract) in Epidermolysis Bullosa (ISPOR-EU 2023) - "This SEE exercise, the first of its kind in EB, validated and provided clinical and resource use assumptions/parameters for a UK-specific CEM evaluating Filsuvez® gel versus SoC in DEB and JEB, used in a submission for NICE highly specialised technology appraisal."

Clinical • Cost effectiveness • HEOR • Genetic Disorders • Infectious Disease • Oncology • Septic Shock • Squamous Cell Carcinoma

Oleogel-S10 for chronic wounds in EB: preliminary result of the real-world experience (EADV 2023) - "The limitations of the study are the real-world setting, the low number of patients, and the variability of the wounds in respect to size and localization. Although the effect was variable and the course of the wounds undulating, all patients continued using Oleogel-S10."

Clinical • Real-world • Real-world evidence • Inflammation • Pain

Oleogel-S10 reduces dressing changes burden in patients with epidermolysis bullosa (EADV 2023) - P3 | "Oleogel-S10 significantly reduced the frequency of daily dressing changes versus control gel in EB patients with the highest burden, and this translated into a relative reduction in the calculated time spent on this procedure. The time saved with Oleogel-S10 has the potential to considerably reduce the negative impact of laborious and painful dressing changes in patients with EB. Figure."

Clinical • Late-breaking abstract • Genetic Disorders • Mood Disorders • Pain

Birch Bark Extract: A Review in Epidermolysis Bullosa. (PubMed, Drugs) - "Birch bark extract was generally well tolerated in patients with EB, with the tolerability profile being similar to that of control gel. Current evidence indicates that birch bark extract is an effective, emerging treatment option for patients with dystrophic and junctional EB."

Journal • Review

New Hope for Treating the 4 Main Types of Epidermolysis Bullosa (DermatologyTimes) - "'Epidermolysis bullosa simplex represents the mildest form of EB, and many of the patients with EBS will tend to get better later on in life,' said Amy S. Paller, MD."

Media quote

Long-term safety and efficacy of Oleogel-S10 in dystrophic epidermolysis bullosa: Sub-analysis from the 24-month open-label EASE study (WCD 2023) - "Oleogel-S10 has a reassuring long-term safety profile. Furthermore, the long-term impact of accelerated wound healing is evident through the sustained reduction in wound burden over time. This is encouraging given the regular reoccurrence of patients’ fragile wounds in the natural course of this disease"

Clinical • Late-breaking abstract • Infectious Disease • Novel Coronavirus Disease • Rare Diseases