News
Talecris gets FDA "orphan drug" designation for inhaled treatment for Alpha-1
The Medical News
Talecris Biotherapeutics has been granted orphan drug designation by the US Food and Drug Administration (FDA) for the development of an aerosol formulation of Alpha1-Proteinase Inhibitor to treat congenital alpha1-antitrypsin (AAT) deficiency.
Alpha-1 Antitrypsin Deficiency (Alpha-1) is a chronic, hereditary condition that increases the risk of lung and liver disease, especially emphysema, which typically emerges in the fourth decade of life.
Currently, there are no approved inhaled treatments available for the treatment of Alpha-1.
Orphan drug designation is granted to companies to encourage the development of treatments that prevent, diagnose or treat rare, life-threatening or chronic illnesses that affect fewer than 200,000 people per year in the US
The designation provides incentives such as tax credits and seven years of market exclusivity to companies willing to support the costly research and development programs associated with developing specialized drugs for a small population of individuals.
Talecris received a similar orphan drug designation for the aerosolized form of AAT from the European Commission in June of 2008.
