Erdosteine Given Orphan Drug Status By FDA

Edmond Pharma’s drug Erdosteine has been given orphan drug status by the FDA for the treatment of bronchiectasis. Orphan status is typically given to drugs that affect less than 200,000 people within the United States; in turn, the drug producer receives various benefits in return, such as longer exclusivity periods.

Edmond’s CEO, Roberto Teruzzi, spoke about the drug’s approval for orphan status. “We are excited for the achievement of the orphan drug status for erdosteine, thanks to the commitment of our U.S. partner Alitair Pharmaceuticals,” said Teruzzi. “This result represents a very important achievement in the process of worldwide expansion of our group and I believe it is a source of pride for the pharmacological research made in Italy. The market potential of this new therapy in the United States is considerable and corresponds to a therapeutic unmet need. Indeed there are no other drugs approved by the FDA for the treatment of bronchiectasis, a condition which has a heavy impact on the quality of life of the people affected.”

Bronchiectasis, the destruction and widening of the large airways, is typically caused by inflammation and infection of the airway. As the disease gets worse it can cause airways to become scarred and damaged.

Edmond Pharma is already marketing erdosteine in 40 different nations around the world for the treatment of COPD and chronic bronchitis. The company is now starting the process of getting the drug approved for use in the United States. Edmond Pharma plans to test erdosteine in a clinical trial setting in the United States. The company believes that a successful clinical outcome will lead to final authorization for erdosteine as an orphan drug.