Arrowhead Gets FDA Breakthrough Status for Liver Treatment

Arrowhead Pharmaceuticals said the U.S. Food and Drug Administration granted Breakthrough Therapy designation for ARO-AAT as a treatment for the rare genetic liver disease associated with alpha-1 antitrypsin deficiency.

• The treatment, also known as TAK-999, is the company’s second-generation investigational RNA interference therapeutic being co-developed with Takeda Pharmaceutical
• Investigational therapy ARO-AAT was also previously granted Orphan Drug designation and Fast Track designation from the FDA, and Orphan designation from the European Commission
• Arrowhead shares advanced as much as 3.6% in premarket trading

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Luzi Ann ...