Glassia (alpha antitrypsin IV) approved by FDA for use at home in alpha 1 antitrypsin deficiency- Shire and Kamada
Shire and Kamada announced that the FDA has approved an expanded label for Glassia (alpha antitrypsin IV), marking the first treatment for adult patients with emphysema due to severe Alpha-1 Antitrypsin (AAT) Deficiency that can be self-infused at home after appropriate training.
Approved in 2010, Glassia is the first and only liquid ready-to-use augmentation product approved for treatment of clinically evident emphysema due to severe AAT Deficiency. Kamada and Baxalta (formerly Baxter International Inc�s BioScience business and now part of Shire) entered into an exclusive strategic cooperation agreement for the distribution and license of GLASSIA in 2010. Under the terms of the agreement, Baxalta is the exclusive distributor of Glassia in the U.S., Canada, Australia and New Zealand, and is licensed to produce Glassia using Kamada�s technology at a Baxalta facility for sales in those countries.