EMA Accepts Marketing Authorization Application for Oleogel-S10

Birken AG has announced that the European Medicines Agency (EMA) has accepted its Oleogel-S10 Marketing Authorization Application (MAA) for review. Birken’s MAA seeks approval of Oleogel-S10 ointment for accelerated healing of partial thickness wounds.

Dr Armin Scheffler, board member at Birken AG and inventor of Oleogel-S10, stated: “We are very happy about EMA’s acceptance of our MAA submission for review. This is an important milestone in the development of Oleogel-S10 and the history of Birken AG. Partial thickness wounds are painful and at risk for infections and wound healing complications, therefore an acceleration of the healing process would be very beneficial. Oleogel-S10 addresses an unmet medical need, as no other pharmaceutical is currently approved by the EMA for accelerated healing of partial thickness wounds. Birken is dedicated to bring this new therapeutic option to hospitals and patients.”

The submission includes results from the three Phase III trials that have demonstrated a significantly faster wound healing with Oleogel-S10 compared to current standard of care consisting mainly of applying wound dressing materials.

The EMA will review the application under the centralised marketing authorisation procedure. If approved by the EMA, Oleogel-S10 would receive marketing authorization in all 28 member states of the European Union (EU), as well as in Iceland, Liechtenstein and Norway. Birken anticipates a decision until end of 2015.