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Intravenous AAT
(Alpha-1 Antitrypsin)Indications
For chronic replacement therapy in individuals with congenital Alpha-1 Antitrypsin deficiency with demonstrable panacinar emphysema
Characteristics
Ready to use liquid for intravenous administration, 2% in 50 ml solution
Status
 Kamada Has Successfully Met the Primary Endpoint in Its US-FDA Phase III Clinical Trial with Intravenous AAT (April /2008)
Pivotal Phase III Data Confirms Efficacy and Safety of Intravenous Alpha-1 Antitrypsin; Data will be submitted for presentation at an upcoming major medical conference; BLA filing on track for 2009 (October/2008)
Profile
Kamada's intravenous AAT product is the only available product presented in a stable, ready-to-use liquid form. In addition to its high safety profile, it is also stabilizer free and one of the purest products at present on the market. The product is registered in some countries, and used under "compassionate use" programs in other countries.
According to the US Alpha-1 Foundation:
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Alpha 1 Antitrypsin Deficiency is the most prevalent, potentially fatal, under-diagnosed disease |
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Approximately 3% of COPD patients have Alpha-1 Antitrypsin deficiency |
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Alpha-1 has been identified in virtually all populations and ethnic groups. |
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It is estimated that as many as 1 in every 2,500 subjects have Alpha-1 |
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