By Colin Kellaher

 

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

The Pasadena, Calif., biopharmaceutical company said a Phase 2 study of the drug, which it is co-developing with Japan's Takeda Pharmaceutical Co., recently reached full enrollment of 40 patients.

The FDA's breakthrough-therapy designation aims to expedite the development and review of a drug for serious conditions when preliminary clinical evidence shows the drug may show substantial improvement over available therapies.

ARO-AAT previously received orphan-drug and fast-track designations from the FDA, along with orphan designation from the European Commission.

 

Write to Colin Kellaher at colin.kellaher@wsj.com

 

(END) Dow Jones Newswires

July 29, 2021 09:18 ET (13:18 GMT)

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