Birch triterpenes

(Filsuvez®)

Filsuvez®

Drug updated on 12/11/2024

Dosage FormGel (topical; 10%)
Drug ClassBotanical
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for the treatment of wounds associated with dystrophic and junctional epidermolysis bullosa in adult and pediatric patients 6 months of age and older.

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Summary
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  • This summary is based on the review of one randomized controlled trial. [1]
  • Oleogel-S10 (birch triterpenes) achieved complete closure of the target wound in 41.3% of patients within 45 days, compared to 28.9% in the control group.
  • The relative risk (RR) for wound closure with Oleogel-S10 compared to the control gel was 1.44 (95% confidence interval (CI), 1.01 to 2.05; P = 0.013), indicating a statistically significant improvement in wound healing.
  • The study population included patients with dystrophic, junctional, or Kindler epidermolysis bullosa (EB), with target wounds of partial thickness lasting between 21 days and 9 months, sized 10-50 cm². However, no specific subgroup analysis based on EB types was reported.
  • Adverse events (AES) were reported in 81.7% of patients treated with Oleogel-S10 and 80.7% of patients using the control gel. Most AEs were mild to moderate, with 4.6% being severe.
  • The frequency and intensity of AEs were similar between the Oleogel-S10 and control gel groups, with no significant safety concerns or adverse effects specific to particular population types or subgroups noted.
  • The study population included patients with dystrophic, junctional, or Kindler EB, with target partial-thickness wounds lasting between 21 days and 9 months and sized 10-50 cm². The abstract does not provide further details on effectiveness or safety outcomes across different EB subtypes or other specific subgroups.

Product Monograph / Prescribing Information

Document TitleYearSource
Filsuvez (birch triterpenes) Prescribing Information.2024Chiesi USA, Inc.,

Randomized Controlled Trials