PASADENA, Calif. — Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced that the Chinese National Medical Products Administration (NMPA) has approved REDEMPLO® (plozasiran) for the reduction of triglyceride levels in adult patients with familial chylomicronemia syndrome (FCS). FCS is a severe, rare disease characterized by triglyceride levels that can be 10 to 100 times higher than normal leading to a substantially higher risk of developing acute, recurrent, and potentially fatal pancreatitis.
REDEMPLO will be marketed in Greater China by Sanofi under an agreement between Sanofi and Arrowhead. In 2025, Sanofi purchased those rights from Visirna, a majority-owned subsidiary of Arrowhead created to develop and commercialize four of Arrowhead’s investigational cardiometabolic candidates in Greater China.
Approval in China marks the third regulatory approval for REDEMPLO, following recent approvals by U.S. Food and Drug Administration (FDA) and Health Canada, as an adjunct to diet to reduce triglycerides in adults with FCS. REDEMPLO is also in review for marketing authorization by additional global regulatory authorities.
REDEMPLO is the first and only U.S. FDA-approved, Health Canada-approved, and China NMPA-approved siRNA medicine for people living with FCS and can be self-administered at home with a simple subcutaneous injection once every three months.
“NMPA approval of REDEMPLO for FCS in China is another positive step and continues the strong momentum since launching in the U.S. in November 2025. We look forward to working with Sanofi, an innovative global company with an established presence in China,” said Christopher Anzalone, Ph.D., President and CEO at Arrowhead Pharmaceuticals. “We are happy to report encouraging initial response from physicians and patients following FDA approval and launch in the U.S. last month. We intend to continue building on this rapid progress and anticipate additional commercial launches in 2026, pending regulatory review and approval.”
About FCS
Familial chylomicronemia syndrome (FCS) is a severe and rare disease leading to extremely high triglyceride (TG) levels, typically over 880 mg/dL. Such severe elevations can lead to various serious signs and symptoms including acute and potentially fatal pancreatitis, chronic abdominal pain, diabetes, hepatic steatosis, and cognitive issues. Currently, there are limited therapeutic options to adequately treat FCS.
About REDEMPLO® (plozasiran)
REDEMPLO (plozasiran) is approved by the U.S. Food and Drug Administration, Health Canada, and the Chinese National Medical Products Administration as an adjunct to diet to reduce triglycerides for adults with Familial Chylomicronemia Syndrome (FCS). REDEMPLO is an siRNA therapeutic designed to suppress the production of apoC-III, a protein produced in the liver that raises triglyceride levels by slowing their breakdown and clearance. By targeting apoC-III with sustained silencing, REDEMPLO delivers significant reductions in triglyceride levels. REDEMPLO is the first and only siRNA FDA-approved treatment studied in both genetically confirmed and clinically diagnosed patients living with FCS.
For more information about REDEMPLO, visit Our Medicines.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
None.
ADVERSE REACTIONS
Most common adverse reactions in REDEMPLO treated patients (incidence ≥10% of patients treated with REDEMPLO and >5% more frequently than with placebo) are hyperglycemia, headache, nausea, and injection site reaction.
Please see full Prescribing Information for REDEMPLO®.
About Plozasiran
Plozasiran is a first-in-class investigational RNA interference (RNAi) therapeutic designed to reduce production of apolipoprotein C-III (apoC-III) which is a component of triglyceride rich lipoproteins (TRLs) and a key regulator of triglyceride metabolism. ApoC-III increases triglyceride levels in the blood by inhibiting breakdown of TRLs by lipoprotein lipase and uptake of TRL remnants by hepatic receptors in the liver. The goal of treatment with plozasiran is to reduce the level of apoC-III, thereby reducing triglycerides and restoring lipids to more normal levels.
In addition to the FDA approval of REDEMPLO as an adjunct to diet to reduce triglycerides for adults with Familial Chylomicronemia Syndrome, plozasiran has been submitted to additional global regulatory authorities for review and marketing authorization. Plozasiran is also being investigated in the SHASTA-3, SHASTA-4, and SHASTA-5 Phase 3 studies in patients with severe hypertriglyceridemia and the MUIR Phase 3 study in patients with mixed hyperlipidemia.
About Arrowhead Pharmaceuticals
Arrowhead Pharmaceuticals develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead’s RNAi-based therapeutics leverage this natural pathway of gene silencing.
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Contacts
Arrowhead Pharmaceuticals, Inc.
Vince Anzalone, CFA
626-304-3400
[email protected]
Investors
LifeSci Advisors, LLC
Brian Ritchie
212-915-2578
[email protected]
Media
HAVAS PR
Erick Edwing
941-468-7534
[email protected]