FDA approves topical Filsuvez for epidermolysis bullosa

Key takeaways:

• Filsuvez is a topical gel made from a dry extract from two species of birch bark.
• A phase 3 trial found complete wound closure in 43% of patients treated with Filsuvez gel.

Chiesi Global Rare Disease’s topical gel Filsuvez has received FDA approval for the treatment of epidermolysis bullosa, the company announced in a press release.

Filsuvez (birch triterpenes), a topical gel that contains a dry extract from two species of birch bark, is applied to wounds at home during dressing changes.

This approval from the FDA indicates Filsuvez for patients aged 6 months and older with both junctional and dystrophic epidermolysis bullosa.

It was based on evidence from the phase 3 EASE trial, which included 223 patients across 28 countries. Of those patients treated with Filsuvez, 41.3% achieved complete target wound closure within 45 days.

“The FDA’s decision to approve Filsuvez provides those living with EB a safe and effective treatment option for the most prominent and difficult symptom of EB — open wounds that may not heal,” Brett Kopelan, executive director of debra of America, said in the release.

The European Commission approved Filsuvez for this indication in June 2023.

Chiesi Global Rare Diseases acquired Filsuvez as part of its acquisition of Amryt Pharma in early 2023. While under Amryt, Filsuvez, then known as oleogel-S10, was issued a complete response letter in March 2022 from the FDA rejecting it for approval citing the need for additional efficacy evidence.