Filsuvez FDA Approval History
Last updated by Judith Stewart, BPharm on Jan 31, 2024.
FDA Approved: Yes (First approved December 19, 2023)
Brand name: Filsuvez
Generic name: birch triterpenes
Dosage form: Topical Gel
Previous Name: Oleogel-S10
Company: Chiesi Global Rare Diseases
Treatment for: Epidermolysis Bullosa
Filsuvez (birch triterpenes) is a topical birch bark extract indicated for the treatment of wounds associated with dystrophic epidermolysis bullosa and junctional epidermolysis bullosa in adult and pediatric patients 6 months of age and older.
- Epidermolysis bullosa is a debilitating genetic skin disease that causes the skin to be so fragile it can be injured just from touch. There are four main types of epidermolysis bullosa, including dystrophic epidermolysis bullosa (DEB) and junctional epidermolysis bullosa (JEB).
- Filsuvez is a topical gel that contains a dry extract from two species of birch bark. The extract consists of naturally occurring substances known as triterpenes, including betulin, betulinic acid, erythrodiol, lupeol and oleanolic acid. Filsuvez has been shown to promote healing of wounds associated with DEB and JEB although the exact mechanism of action is unknown.
- FDA approval of Filsuvez was based on results from the Phase 3 EASE trial. The primary endpoint of the trial was to compare the efficacy of Filsuvez topical gel versus control gel according to the proportion of patients with complete closure of the target wound within 45 days of treatment. The primary endpoint was achieved with statistical significance (p-value = 0.013).
- Filsuvez topical gel is administered directly to the wound surface at each wound dressing change until the wound is healed.
- Warnings and precautions associated with Filsuvez include hypersensitivity reactions.
- Common adverse reactions include application site reactions.
Development timeline for Filsuvez
Further information
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