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Brazil approves Kamada augmentation therapy for Alpha-1
Globes
Israeli pharmaceutical specialty company Kamada Ltd. has obtained approval from Brazil’s National Health Surveillance Agency (Anvisa) for its Alpha-1 Antitrypsin (AAT) protein for the treatment of Alpha-1 Antitrypsin Deficiency (Alpha-1). Kamada estimates Brazilian sales of AAT at over $1 million in 2010.
Kamada is awaiting approval from the US Food and Drug Administration to market its AAT product in the United States. When approved, it would be the fourth intravenous augmentation therapy for Alpha-1 in the US.
Anvisa granted the approval after visiting Kamada’s plant and reviewing the registration file. The approval was the final step before marketing AAT in Brazil. Kamada will market AAT through a local distributor.
