Arrowhead Pharmaceuticals Gets FDA Breakthrough Designation for Plozasiran

Dow Jones09-10

By Colin Kellaher

Arrowhead Pharmaceuticals has won Food and Drug Administration breakthrough-therapy designation for its proposed plozasiran therapeutic in a rare genetic disease that prevents the body from digesting fats.

Arrowhead on Tuesday said the designation covers plozasiran as an adjunct to diet to reduce triglycerides in adults with familial chylomicronemia syndrome, a disease characterized by extremely high triglyceride levels that can cause acute and potentially fatal pancreatitis.

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.

Arrowhead said there are currently no approved treatments in the U.S. for familial chylomicronemia syndrome.

The Pasadena, Calif., biopharmaceutical company said a Phase 3 study has shown that plozasiran reduced triglycerides by 80% from baseline and reduced the risk of developing acute pancreatitis by 83% in patients with genetically confirmed and clinically diagnosed familial chylomicronemia syndrome.

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

(END) Dow Jones Newswires

September 10, 2024 07:44 ET (11:44 GMT)

Copyright (c) 2024 Dow Jones & Company, Inc.

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