Shire, Kamada: FDA Approves Expanded Label For Self-infusion Of GLASSIA

(RTTNews) - Biotechnology company Shire plc (SHP.L, SHPG) and Kamada Ltd. (KMDA), a plasma-derived protein therapeutics company focused on orphan indications, announced Wednesday that the United States Food and Drug Administration has approved an expanded label for GLASSIA. This marks the first treatment for adult patients with emphysema due to severe Alpha-1 Antitrypsin Deficiency, that can be self-infused at home after appropriate training.

Patients with Alpha-1 Antitrypsin or AAT Deficiency have low or undetectable levels of a protein called alpha-1 antitrypsin or AAT, which helps protect lung tissue from damaging enzymes that are released by white blood cells. AAT deficiency can result in early onset emphysema.

The companies noted that treatment with GLASSIA replaces the missing or deficient AAT protein in the blood and lungs.

GLASSIA, approved in 2010, 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.