In March 2022, the U.S. Food and Drug Administration (FDA) decided against the approval of oleogel-S10 for epidermolysis bullosa (EB); the FDA noted that, prior to approval, it would need more evidence that the treatment was effective in healing the open wounds associated with the condition. However, data from the Phase 3 EASE study supported oleogel-S10’s efficacy. The treatment, now known as Filsuvez, was recently approved by the FDA, reports Healio.
The Phase 3 trial enrolled 223 participants with EB. After receiving Filsuvez, 41.3% of treated individuals experienced total wound healing and closure within 45 days (approx. 1.5 months).
Filsuvez topical gel is consists of 10% birch triterpenes supplied in 25 mL sterile tubes. Its approval means that people with dystrophic epidermolysis bullosa (DEB) or junctional epidermolysis bullosa (JEB) ages 6 months or older now have a new therapeutic option. Learn more about Filsuvez here.
Beyond the United States, Filsuvez is also approved for the treatment of JEB and DEB in the European Union (EU).
About Epidermolysis Bullosa
Epidermolysis bullosa refers to a group of genetic skin disorders characterized by fragile, delicate, and easily blistered skin. Caused by a variety of genetic mutations, epidermolysis bullosa causes moderate-to-severe skin blistering from friction on the skin. There are four major forms: epidermolysis bullosa simplex, junctional epidermolysis bullosa, dystrophic epidermolysis bullosa, and Kindler syndrome.
There is a spectrum of severity across all types. Some individuals may experience only mild blistering, while people with severe cases may experience internal blisters in the respiratory system, stomach, esophagus, or intestines. Symptoms also vary across subtypes but may include:
- Widespread blistering of the skin
- Thickened skin on the palms and soles
- Skin itchiness
- Scarring
- Anemia
- Joint contractures
- Thinning hair and/or hair loss
- Eye inflammation
- Ulcerative blisters that can become infected or life-threatening
- Thin-appearing skin
- Thickened, malformed, or missing nails
- Heightened risk of skin cancer
For a full list of symptoms associated with EB, check out this overview from DEBRA.
