The European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended marketing authorization for birch bark extract (Episalvan, Birken AG) for treatment of partial thickness wounds in adults.
Episalvan will be available as a gel for cutaneous use.
Birch bark extract is thought to work by modulating several proinflammatory mediators in the first days of wound healing and by helping keratinocytes to restore the damaged skin epithelial tissue, the EMA said in a news release.
“The benefits with Episalvan are its ability to reduce the healing time of wounds where the upper layers of the skin have been damaged, for example by a burn or during surgical skin grafting. The most common side effects are itching and pain in the area where the product is applied and complications in the wound healing process,” the agency said.
Detailed recommendations for use of Episalvan will be described in the summary of product characteristics, which will be published in the European public assessment report and made available in all official European Union languages after the European Commission grants marketing authorization.