Erdosteine Designated Orphan Drug for Bronchiectasis

Edmond Pharma announced that the FDA has granted Orphan Drug status to erdosteine, a molecule being developed for the treatment of bronchiectasis.

Erdosteine is a thiol, with muco-modulatory, anti-bacterial, anti-inflammatory and anti-oxidant properties that makes it effective for the treatment of multiple respiratory diseases, such as acute bronchitis (AB), chronic bronchitis (CB) and chronic obstructive pulmonary disease (COPD). It modulates mucus production and viscosity and increases the motility of the mucociliary transport, thus improving expectoration.

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The clinical efficacy of erdosteine was studied in more than 3,000 patients treated in 60 clinical trials. Several studies on CB and COPD are currently ongoing in Europe, involving approximately 600 patients from 10 different countries. It is now being used in studies targeted on bronchiectasis, conducted in the US as part of the clinical development plan aimed to obtain orphan drug status.

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