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FDA OOPD: orphan drug designation for Erdosteine in bronchiectasis


Office of Orphan Products Development ( OOPD ) of the Food and Drug Administration ( FDA ) has granted orphan drug designation for drug candidate, Erdosteine, for the treatment of bronchiectasis.
Erdosteine is a mucolytic with antibacterial, anti-inflammatory, and antioxidant properties.

Erdosteine is currently approved for the treatment of COPD and chronic bronchitis in 50 countries outside of the U.S.

Orphan drug designation is granted by the FDA OOPD to drug therapies intended to treat a rare disease or condition affecting fewer than 200,000 patients in the U.S.

Bronchiectasis is a condition in which the lungs produce excessive amounts of mucus. Cystic fibrosis is the best known disease that causes bronchiectasis.
In bronchiectasis, the mucus builds up in the airways, allowing bacteria to grow, which leads to recurring infections. Each infection causes more damage to the airways, impairing the airways' ability to move air in and out of the lungs.
Bronchiectasis can lead to serious health problems including respiratory failure, atelectasis, heart failure, and death.

Erdosteine is a thiol derivative developed for the treatment of chronic obstructive bronchitis, including acute infective exacerbation of chronic bronchitis, bronchiectasis, and other respiratory diseases.
Erdosteine modulates mucus production and viscosity and increases mucociliary transport, thereby improving expectoration. It also exhibits inhibitory activity against the effects of free radicals.
Clinical studies in patients with chronic obstructive lung disease have demonstrated the efficacy and tolerability of Erdosteine. Erdosteine is associated with a low incidence of adverse events, most of which are gastrointestinal and generally mild. ( Xagena )

Source: Alitair Pharmaceuticals, 2014

XagenaMedicine_2014



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