MediWound gets EU Approval
The European Medicines Agency (EMA) has recommended to grant MediWound marketing authorization for NexoBrid™ in the European Union (EU) for removal of eschar in adult patients with deep partial- and/or full-thickness thermal burns. This approval follows EMA’s Good Manufacturing Practices (cGMP) approval for MediWound’s sterile manufacturing plant and laboratories. NexoBrid™ has shown statistically significant effect in earlier eschar removal from partial and/or full thickness burns in a number of multi-national, multi-centered, controlled clinical studies. The drug consists of a mixture of enzymes extracted from the stem of the pineapple plant. NexoBrid™ removes the eschar after a single 4 hour topical application without harming viable tissues, enabling earlier successful eschar removal and direct visual assessment of the burn’s depth for informed decision on further treatment. Moreover, the effective non surgical eschar removal allows significant reduction in the number and extent of surgical excision and autografting.