On November 18, 2025, Arrowhead Pharmaceuticals, Inc. (ARWR) announced that the U.S. Food and Drug Administration (FDA) approved REDEMPLO (plozasiran) for the treatment of adults with familial chylomicronemia syndrome (FCS). Arrowhead has set a wholesale acquisition cost (WAC) for REDEMPLO of $60,000 per year. This is approximately 1/10th of the cost of Tryngolza, although Ionis Pharmaceuticals has stated that if approved to treat severe hypertriglyceridemia (SHTG) the price of Tryngolza would be in the $10,000-$20,000/yr range. With the approval in FCS, Arrowhead is initially focused on the approximately 6,500 FCS patients in the U.S. However, the company recognizes the much larger potential commercial opportunity in SHTG, for which the drug is currently being tested in the SHAST-3, SHASTA-4, and MUIR-3 studies, with those results expected in the third quarter of 2026.
19 Nov 2025
ARWR: REDEMPLO Approved by FDA for the Treatment of FCS
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ARWR: REDEMPLO Approved by FDA for the Treatment of FCS
- Published:
19 Nov 2025 -
Author:
David Bautz -
Pages:
5 -
On November 18, 2025, Arrowhead Pharmaceuticals, Inc. (ARWR) announced that the U.S. Food and Drug Administration (FDA) approved REDEMPLO (plozasiran) for the treatment of adults with familial chylomicronemia syndrome (FCS). Arrowhead has set a wholesale acquisition cost (WAC) for REDEMPLO of $60,000 per year. This is approximately 1/10th of the cost of Tryngolza, although Ionis Pharmaceuticals has stated that if approved to treat severe hypertriglyceridemia (SHTG) the price of Tryngolza would be in the $10,000-$20,000/yr range. With the approval in FCS, Arrowhead is initially focused on the approximately 6,500 FCS patients in the U.S. However, the company recognizes the much larger potential commercial opportunity in SHTG, for which the drug is currently being tested in the SHAST-3, SHASTA-4, and MUIR-3 studies, with those results expected in the third quarter of 2026.