Arrowhead Gets FDA Breakthrough Therapy Designation for ARO-AAT

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 [e-mail]

(END) Dow Jones Newswires

07-29-21 0918ET