Kamada Gets ODD from FDA for Type 1 Diabetes Treatment
FDA grants an orphan drug designation for Kamada's Alpha-1 Antitrypsin drug to treat type 1 diabetes.
Biopharmaceutical company Kamada has received an orphan drug designation (ODD) from the US 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.
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