Biopharmaceutical company Kamada has been granted an orphan drug designation (ODD) by the US Food and Drug Administration (FDA) for its Alpha-1 Antitrypsin (AAT) drug to treat type 1 diabetes.
The company is currently undergoing a Phase I/II clinical trial with AAT by IV route of administration.
AAT IV was granted FDA approval in July 2010 for the treatment of Alpha 1 deficiency and is exclusively marketed by Baxter in the US.
Kamada’s next-generation AAT by inhalation is currently undergoing a Phase 2-3 trial in Europe.
The company has already completed five clinical trials with its high purity, liquid formulation of inhaled Alpha-1 Antitrypsin.