Biotherapeutics company CSL Behring reported on Thursday the receipt of US Food and Drug Administration (FDA) approval in 4- and 5-gram vial sizes for ZEMAIRA [Alpha1-Proteinase Inhibitor (Human)]therapy for treating Alpha 1 Antitrypsin Deficiency (Alpha 1).

Alpha 1 is a hereditary condition that can severely affect a patient's lung function. The condition is marked by a low level or absence of AAT, a natural protein that inhibits neutrophil elastase, thereby preventing destruction of lung tissue. Severe deficiency of AAT is associated with a strong tendency for the development of emphysema, a form of chronic obstructive pulmonary disease (COPD), and can significantly impact everyday life and life expectancy.

Previously, ZEMAIRA was only available in a 1-gram vial. The 4- and 5-gram packaging reduces the number of vials necessary for reconstitution, thereby adding convenience by saving patient's time and reducing waste.

ZEMAIRA dosing is weight-based, so a patient weighing 184 pounds currently requires five 1-gram vials. With the larger vial sizes, a majority of patients will be able to streamline their preparation of ZEMAIRA to a single vial per dose.

According to the company, ZEMAIRA is a highly-purified form of AAT (human) currently approved in the US, Canada, Brazil and New Zealand for chronic augmentation and maintenance therapy in adults with Alpha 1 Antitrypsin Deficiency and clinical evidence of emphysema. ZEMAIRA is marketed as Respreeza in Europe.