Intravenous AAT – Kamada's Alpha-1 Antitrypsin for intravenous administration
Aerosolized AAT – Alpha-1 Antitrypsin for aerosolized administration utilizing PARI's eFlow® device
PARI's eFlow® - a portable, electronic aerosol platform that utilizes advanced technology to increase the efficiency and effectiveness of medication delivery while significantly decreasing standard treatment times.
Alpha-1 Foundation – The Alpha-1 Foundation is a not-for-profit Florida corporation dedicated to providing the leadership and resources that will result in increased research, improved health, worldwide detection, and a cure for Alpha-1.
US FDA – American Food and Drug Administration
EMEA – European Medicines Agency
Orphan Product Designation (ODD) – Orphan designation qualifies the sponsor of the product for the tax credit and marketing incentives of the ODA.
IND - investigational new drug
IMPD - Investigational Medicinal Product Dossier (EU)
BLA - biologics license application (CBER)
MAA - Marketing Authorisation Application
Bronchiectasis - Bronchiectasis is an abnormal stretching and enlarging of the airways. Bronchiectasis patients usually suffer from recurrent, severe episodes of bronchitis, chronic cough and sputum production.. According to the US COPD foundation approximately 600,000 individuals suffer from bronchiectasis worldwide, with an estimated 100,000 people in the US alone (excluding cystic fibrosis patients).
Cystic Fibrosis - (also known as CF, mucovoidosis, or mucoviscidosis) is a hereditary disease affecting the exocrine (mucus) glands of the lungs, liver, pancreas, and intestines, causing progressive disability due to multisystem failure.
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