General Information

Filsuvez (birch triterpenes) contains a dry extract from two species of birch bark consisting of naturally occurring substances known as triterpenes, which have anti-inflammatory, antiviral, antimicrobial, antitumoral and immunomodulating effects. 

Filsuvez is specifically indicated for the treatment of wounds associated with dystrophic and junctional epidermolysis bullosa (EB) in adult and pediatric patients 6 months of age and older.

Dosing/Administration

• Filsuvez is supplied as a topical gel. 
• Wash hands before and after applying Filsuvez or wear gloves for application.
• Apply a 1 mm layer of Filsuvez to the affected wound surface only. Do not rub in the gel. Cover the wound with a sterile non-adhesive wound dressing. Alternatively, apply Filsuvez directly to the dressing so that the topical gel is in direct contact with the wound.
• Apply Filsuvez to cleansed wounds with wound dressing changes until the wound is healed.  
• If a Filsuvez -treated wound becomes infected, discontinue treatment to that wound until the infection has resolved.
• Each tube of Filsuvez is for one-time use only. Once the tube is opened, use the product immediately.
•  Avoid contact of Filsuvez with eyes and mucous membranes (e.g., mouth, vagina, anus). In case of accidental contact, irrigate the area with water.
•  Filsuvez is for topical use only. Not for use on mucous membranes and not for ophthalmic use.

Mechanism of Action

Filsuvez (birch triterpenes) contains a dry extract from two species of birch bark consisting of naturally occurring substances known as triterpenes, including betulin, betulinic acid, erythrodiol, lupeol and oleanolic acid. The mechanism by which Filsuvez works in the treatment of wounds associated with epidermolysis bullosa is unknown.

Side Effects

The most common adverse reaction associated with the use of Filsuvez is application site reactions.

Clinical Trial Results

The FDA approval of Filsuvez was based on the phase 3 EASE trial, which comprised a 3-month double-blind randomized controlled phase followed by a 24-month open-label, single-arm phase. Patients with EB target wounds of between 10 and 50cm2 in size that were present for > 21 days and < 9 months were randomized in the double-blind phase to study treatment in a 1:1 ratio and wound dressings applied according to the standard of care. 223 patients were enrolled in the trial including 156 pediatric patients. Of those who completed the double-blind phase, 100% entered the open-label safety follow-up phase. 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. While the key secondary endpoints did not achieve statistical significance, a number of favorable differences were observed.