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Filsuvez (birch bark extract)
Filsuvez works by targeting the underlying cause of Epidermolysis bullosa to reduce skin blistering.
At a glance
| Generic name | birch bark extract |
|---|---|
| Sponsor | Amryt Pharmaceuticals Dac |
| Therapeutic area | Dermatology |
| Phase | FDA-approved |
Mechanism of action
Imagine your skin is made up of layers, and in Epidermolysis bullosa, these layers are fragile and easily damaged. Filsuvez helps to strengthen these layers, making it easier for people with this condition to manage their symptoms and prevent blisters.
Approved indications
- Epidermolysis bullosa
Common side effects
- Application site reactions
- Application site pruritus
- Administration site pain
- Administration site pruritus
Serious adverse events
- Squamous cell carcinoma of the skin
- Hypersensitivity reactions
Key clinical trials
- A Study to Learn About the Safety and Efficacy of the Drug Oleogel-S10 in Japanese Patients With Epidermolysis Bullosa (PHASE3)
- A Study of Oleogel-S10 Gel for the Treatment of Radiation Dermatitis in People With Breast Cancer (PHASE2)
- A Study to Assess the Incidence of Skin Cancers in Patients With Epidermolysis Bullosa Receiving Filsuvez
- Phase III Efficacy and Safety Study of Oleogel-S10 in Epidermolysis Bullosa (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Filsuvez CI brief — competitive landscape report
- Filsuvez updates RSS · CI watch RSS
- Amryt Pharmaceuticals Dac portfolio CI