FDA approves expanded label for emphysema treatment Glassia

Kamada and Baxalta (formerly Baxter International’s BioScience business and now part of Shire) entered into a cooperation agreement in 2010 for the distribution and license of Glassia, which can be self-infused at home after relevant training.

Baxalta is the exclusive distributor of Glassia in the US, Canada, Australia and New Zealand, and is licensed to manufacture the product using Kamada’s technology at a Baxalta plant for sales in those countries.

Shire US immunology franchise head Blaine Forshage said: "With this new label for GLASSIA, we’re now able to offer the only AAT augmentation treatment that is approved for patients to self-administer at home, helping to deliver on our goals to support the Alpha-1 community."

Glassia is an Alpha1-Proteinase Inhibitor (Human) (Alpha1-PI) indicated for chronic augmentation and maintenance therapy in adults with clinically evident emphysema because of severe hereditary deficiency of Alpha1-PI (alpha1 antitrypsin deficiency).

It increases antigenic and functional serum levels and antigenic lung epithelial lining fluid levels of Alpha1-PI.

Patients with AAT deficiency have low or undetectable levels of a protein called alpha-1 antitrypsin, which helps in protecting lung tissue from damaging enzymes that are released by white blood cells.

AAT deficiency can lead to early onset emphysema. Treatment with Glassia replaces the missing or deficient AAT protein in the blood and lungs.