Clal Biotechnology Industries announced that MediWound has applied to the European Medicines Agency (EMA) for marketing approval of its new drug, Nexobrid, previously known as Debrase.
After the completing of Phase III, the drug now is submitted through the centralized procedure of approval. Succesful completing of this process, which is expected to take about a year, will allow marketing the drug in all EU member states. Exclusive distribution rights belong to Teva Pharmaceutical Industries.
Nexobrid received orphan medication designation in the EU and U.S. “Orphan drugs” are medicinal products intended for diagnosis, prevention or treatment of life-threatening or very serious diseases affecting less than five in 10 000 people (by EU standards) or less than 200.000 people in the U.S. Nexobrid is an enzymatic based debriding agent, which is to be used for the dissolution of necrotic burned tissue in deep partial thickness and full thickness burns. The product is an effective, selective, fast and safe alternative to current debriding means, such as surgery and non-surgical methods.
Gal Cohen (MediWound CEO) said: “Completion of development of this designated drug and submission for approval for commercialization in Europe is a rare event in the Israeli biomed industry. It’s a great privilege to be a part of the long and complex endeavor. We’ve taken another great step forward on the road to international marketing of the drug, and we’ll continue to work hard to complete the commercialization process of the drug.”
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