NESS ZIONA, Israel--(BUSINESS WIRE)--Kamada Ltd. (NASDAQ:KMDA) (TASE:KMDA), a plasma-derived protein therapeutics company focused on orphan indications, announces that the U.S. Food and Drug Administration’s (FDA) Office of Orphan Products Development has granted orphan drug designation for Glassia®, the Company’s proprietary human Alpha-1 Antitrypsin (AAT), to treat Graft-versus-host-disease (GVHD). Orphan drug designation carries multiple benefits, including the availability of grant money, certain tax credits and seven years of market exclusivity, as well as the possibility of an expedited regulatory process.
Preliminary human and animal studies indicate that Glassia may be able to treat and reduce the severity of GVHD, which is one of the key, life threatening complications of allogeneic stem cell transplantation. GVHD is an immunologically-based disease that may result in significant damage to the recipients’ health including damage to multiple organs and tissues such as the liver, gastrointestinal tract, skin and mucosal membranes. Tissue destruction also leads to increased inflammatory signals, perpetuating and augmenting the disease process by contributing to the cytokine storm that fuels GVHD even further and, thereby, the damage continues and its intensity is increased.
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