By Connor Hart

Arrowhead Pharmaceuticals said Friday that the Food and Drug Administration accepted the company's new drug application for its treatment of familial chylomicronemia syndrome, a severe and rare genetic disease.

The drug, plozasiran, is expected to have its commercial launch later this year, pending final FDA review and approval, Chief Executive Chris Anzalone said.

"Plozasiran has achieved promising and consistent results in various patient populations representing multiple points on the spectrum of diseases caused by elevated triglycerides," he said.

A Phase 3 study of the drug resulted in what the company called "deep and durable reductions in triglycerides," which are the main component of body fat.

Familial chylomicronemia syndrome, or FCS, represents the most severe end of the spectrum of diseases caused by elevated triglycerides, according to the company. The disease leads to extremely high levels of the fat, resulting in various signs and symptoms including acute and potentially-fatal pancreatitis, chronic abdominal pain and diabetes.

Arrowhead said it intends to investigate plozasiran as a treatment for other diseases on that spectrum, including severe hypertriglyceridemia and mixed hyperlipidemia.

Write to Connor Hart at connor.hart@wsj.com

(END) Dow Jones Newswires

January 17, 2025 16:58 ET (21:58 GMT)

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