FDA Grants Orphan Drug Designation To Talecris’ New Aerosolized Formulation

Reportedly, Alpha1-Proteinase Inhibitor (Human, A1PI) will be an aerosol formulation. Talecris has also received an orphan drug designation for the aerosolized form of AAT from the European Commission in June of 2008.

Lawrence Stern, chairman and CEO of Talecris, said: “Talecris is committed to helping patients with rare diseases for whom few treatment options exist. This orphan drug designation will allow us to move forward with developing an alternative method of delivering augmentation therapy for patients who prefer an inhaled mode of administration.”

Moreover, Talecris’ considers its partnership with Activaero Technologies (Activaero) as an important part of its aerosol development program.

Reportedly, AKITA2 APIXNEB inhalation system of Activaero has showed high drug deposition to the central and peripheral regions of the lungs in patients with AAT deficiency, regardless of disease severity.

Talecris manufactures intravenous therapy, Prolastin (Alpha1-Proteinase Inhibitor [Human]) for therapy, involving chronic augmentation for the patients suffering from AAT deficiency.