PASADENA, Calif., August 17, 2026
Arrowhead Pharmaceuticals, Inc. announced that people living with familial chylomicronaemia syndrome (FCS) in Germany now have access to REDEMPLO® (plozasiran) as a new treatment option to reduce dangerously high triglyceride levels. Following the European Commission marketing authorization in June 2026, REDEMPLO has been listed in Germany’s Lauer-Taxe® database, enabling the medicine to be prescribed, dispensed and reimbursed for eligible adults. The treatment is authorized as an adjunct to diet for adults diagnosed with FCS based on clinical symptoms or genetic testing, broadening access beyond approaches that require genetic confirmation. REDEMPLO is administered as a subcutaneous injection once every three months, giving physicians a new treatment option for managing a rare metabolic disease associated with extremely elevated triglycerides and a substantial risk of acute pancreatitis.
REDEMPLO Becomes Available to Eligible FCS Patients
Arrowhead Pharmaceuticals’ German availability milestone represents an important step in translating the European approval of plozasiran into access for patients with FCS. The company said Germany is its first focus country in the European Union as it works toward making REDEMPLO available in additional European markets. FCS is a severe and rare metabolic disorder in which patients can develop extremely high triglyceride concentrations, potentially exceeding 10 mmol/L (880 mg/dL). These elevations can contribute to recurrent and potentially life-threatening acute pancreatitis, as well as other long-term complications that can significantly affect quality of life. The ability to diagnose eligible patients through clinical symptoms or genetic testing is also an important aspect of the authorization, particularly because FCS diagnosis can be challenging and may otherwise involve lengthy genetic confirmation processes.
Phase 3 PALISADE Data Supported European Authorization
The European authorization of REDEMPLO (plozasiran) was supported by findings from the Phase 3 PALISADE study, a placebo-controlled trial evaluating plozasiran in 75 adults with genetically confirmed or clinically diagnosed FCS. The primary endpoint assessed the median percentage change from baseline in fasting triglyceride levels at Month 10 compared with placebo. At the recommended 25 mg dose, plozasiran produced a statistically significant reduction in median fasting triglyceride levels from baseline to Month 10 compared with placebo, with p<0.0001. These findings formed part of the evidence supporting the European marketing authorization and subsequent availability in Germany. The reported adverse reactions included hyperglycaemia, headache, nausea and injection-site reaction, with hyperglycaemia reported as the most common among the listed reactions. The treatment remains focused on reducing triglyceride levels as part of disease management rather than eliminating the underlying genetic cause of FCS.
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Germany Marks First EU Commercial Access Milestone
Arrowhead Pharmaceuticals is using Germany as the first major European access point for REDEMPLO, while continuing the relevant processes required to make plozasiran available in other European countries. The company described the German launch as an important step for patients who face a lifelong risk associated with severe triglyceride elevation and recurrent pancreatitis. The availability of REDEMPLO adds a new treatment option for adults with FCS and expands the commercial reach of Arrowhead’s RNA interference (RNAi) platform. Plozasiran is designed to reduce triglyceride levels through RNAi-mediated gene silencing, representing the company’s approach to developing medicines for diseases with significant unmet medical needs. With Germany now providing prescription, dispensing and reimbursement access following the Lauer-Taxe listing, Arrowhead is moving from regulatory authorization toward broader real-world availability of REDEMPLO for eligible FCS patients across Europe.
Source: Arrowhead Pharmaceuticals press relese
