Kamada Ltd. (TASE: KMDA) has obtained Food and Drug Administration (FDA) approval to conduct a clinical trial in the US for the company&'s next generation drug – an inhalable version of AAT (Alpha-1 Antitrypsin deficiency) for the treatment of cystic fibrosis.
The company will have to meet the FDA guidelines for a Phase II/III trial of inhalable AAT, which is already underway in Europe, in order to submit an Investigational New Drug (NDA) portfolio with the FDA. The current FDA approval is partly based on successful preclinical trials of the drug.