Israeli biopharmaceutical company Kamada Inc. (KMDA.TA) (KAMAF.PK) has been granted approval by the Food and Drug Administration for its intravenous lung drug Glassia, an Alpha-1 Antitrypsin, to treat the genetic disorder Alpha-1 Antitrypsin deficiency.
Alpha-1 Antitrypsin deficiency, or AATD is a shortage or absence of a protein called A-1 Antitrypsin, that blocks the destructive effects of certain enzymes. Lack of this protein can lead to the destruction of lung tissue and cause chronic lung disease such as emphysema. It can also be associated with liver disease in children.
As part of its preparations to market the drug in the United States, the company has set up a U.S. subsidiary called Kamada Inc.
According to the U.S. Alpha-1 Foundation, Alpha 1 Antitrypsin Deficiency is the most prevalent, potentially fatal, under-diagnosed disease. About 3% of COPD (chronic obstructive pulmonary disease) patients have Alpha-1 Antitrypsin deficiency.
The company is also developing an inhaler version of the Alpha-1 Antitrypsin, or AAT. The inhaler version of the Alpha-1 Antitrypsin has been designated Orphan Drug, in both Europe and the U.S. for the treatment of cystic fibrosis and Alpha-1 Antitrypsin Deficiency as well as in the U.S. for the treatment of Bronchiectasis.
Kamada's Alpha-1 Antitrypsin Glassia will now compete with Talecris Biotherapeutics Holding Corp.'s (TLCR) Prolastin, the dominant AAT product in the market. The other AAT therapeutics on the market include , Baxter's Aralast and CSL Behring's Zemaira.
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