Arrowhead receives FDA breakthrough therapy designation for Plozasiran in severe hypertriglyceridemia
- Co announced that the United States FDA has granted Breakthrough Therapy designation to investigational plozasiran as an adjunct to diet to reduce triglyceride (TG) levels in adults with severe hypertriglyceridemia.There are currently limited and inadequate treatment options for the millions of people globally living with SHTG.
- Breakthrough Therapy designation is a process designed to expedite the development and review of drugs that are intended to treat a serious condition and where preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapies on clinically significant endpoints1.
- Arrowhead is on schedule to complete the SHASTA-3, SHASTA-4, and MUIR-3 Phase 3 clinical studies of plozasiran in mid-2026 and intends to submit a supplemental New Drug Application (sNDA) to the FDA by year-end 2026. Arrowhead also plans to seek regulatory approval with additional global regulatory authorities thereafter.