Edmond Pharma’s Erdosteine receives Orphan Drug Status from FDA
The FDA has granted Orphan Drug Status to Erdosteine, a molecule discovered and developed by Italian pharmaceutical company Edmond Pharma. The Orphan Drug Status refers to the new indication for the treatment of bronchiectasis, a rare disease for which no drug therapies currently are approved in the U.S.
The molecule answers to an important unmet therapeutic need and it could reach remarkable performances. The potential for this treatment in the U.S. is expected to exceed $1 billion.
Erdosteine is marketed in over 40 countries worldwide for the treatment of various respiratory diseases, ranging from acute bronchitis to COPD. With a strong presence in Asia, Latin America and Estern Europe, Edmond Pharma is looking for commercial licensing partnership in order to expand its presence in Europe, primarily Germany and France.