Shire and Kamada announced that the Food and Drug Administration (FDA) has approved Glassia (alpha-1 proteinase inhibitor [human]) as the first treatment for adults with emphysema due to severe alpha-1 antitrypsin (AAT) deficiency that can be self-infused at home after appropriate training.
Patients with AAT deficiency can develop early-onset emphysema. Treatment with Glassia increases antigenic and functional (anti-neutrophil elastase capacity, ANEC) serum levels and antigenic lung epithelial lining fluid levels of alpha-1 proteinase inhibitor. Glassia was initially approved in 2010 as the first ready-to-use liquid product for chronic augmentation and maintenance therapy in adults with clinically evident emphysema due to severe AAT deficiency.
Amir London, Kamada’s Chief Executive Officer, stated, “By avoiding the need for reconstitution, our product allows for an overall reduced treatment preparation time. With this new approval, patients have the convenience of self-infusion at home, in addition to potentially reducing costs previously associated with infusion services for administering augmentation therapy in the hospital.
Glassia is available as a single-use vial containing approximately 1g of functional alpha-1 proteinase inhibitor in 50mL solution for injection. It is preservative- and latex-free.
For more information call (866) GLASSIA or visit Kamada.com.