EMA (Avrupa İlaç Ajansı), ananas esaslı etken maddeyi onaylıyor. (İng)



EMA Approves Pineapple-Based Debriding Agent

Yael Waknine

September 24, 2012 — The European Medicines Agency (EMA) has recommended approval of the first enzyme-based debriding agent (NexoBrid, MediWound Ltd) to remove eschar from second- and third-degree burn wounds.

The sterile hydrating gel contains a lyophilized mixture of proteolytic enzymes derived from pineapple plant stems. The medicine removes burn eschar in 4 hours, thereby exposing the wound bed for assessment and subsequent treatment.

Benefits of pharmacologic debridement include a shortened recovery time and decreased risk for excisional surgery, which can cause blood loss, sacrifice of healthy tissue, and worsening of wound severity. Removal of the bacterial load existing in and on the dead tissue also decreases the risk for local and systemic infection.

In a news release, the EMA warns that wounds not treated optimally after pharmacologic debridement can take longer to close and carry an increase risk for adverse events. As a result, the Agency’s Committee for Medicinal Products for Human Consumption is requiring the development of an educational training program to ensure that burn specialists have all the information they need to successfully use the debriding agent.

The pineapple-based debriding agent previously was designated as an orphan drug in 2002.


Authors and Disclosures


Yael Waknine

Yael Waknine is a freelance writer for Medscape.

Yael Waknine has disclosed no relevant financial relationships.