News
FDA agrees to review Kamada Alpha-1 treatment
BioMed Reports
NESS ZIONA, Israel—The Israeli biopharmaceutical company Kamada announced that the United States Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) for intravenous alpha-1 antitrypsin (IV-AAT), the Company’s flagship product for the treatment of Alpha-1 Antitrypsin Deficiency.
Acceptance by the FDA indicates that the submission satisfies the FDA’s preliminary requirements for review. The product will be evaluated within the standard Prescription Drug User Fee Act (PDUFA) timeframe, meaning that a ruling is expected in the second quarter of 2010.
An inspection of Kamada’s manufacturing facilities in Israel is expected to be performed by the FDA during the review period.
Kamada has developed a unique liquid, ready-to-use human plasma derived product for Alpha-1 augmentation therapy. The product is produced using a sophisticated, proprietary chromatographic purification method.
