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Redemplo (plozasiran)
Australian Prescription Medicine Decision Summary
Redemplo has been approved as an adjunct to diet to reduce triglyceride levels for adult patients with genetically confirmed or clinically diagnosed familial chylomicronaemia syndrome (FCS). Redemplo contains the active ingredient plozasiran.
Published
Product name
Redemplo
Active ingredient
Plozasiran
Submission type
New chemical entity - Type A application
Decision
Approved for registration in the Australian Register of Therapeutic Goods (ARTG)
Decision date
Registration date
What this medicine was approved for
Redemplo is approved for use with diet to lower very high triglyceride levels in adults with familial chylomicronaemia syndrome (FCS). It is for people whose usual triglyceride‑lowering medicines have not worked well enough.
FCS is a rare and serious inherited condition that affects the body’s ability to break down triglycerides, a type of fat (lipid) found in the blood.
Very high triglyceride levels can cause serious and sometimes life‑threatening problems. These include inflammation of the pancreas (acute pancreatitis), recurring stomach pain, changes in vision, an enlarged liver or spleen, nausea, vomiting, episodes of confusion, and fatty lumps on the skin.
How this medicine works
In people with FCS, the body lacks a working enzyme called lipoprotein lipase (LPL), which normally helps break down triglycerides. When this enzyme is missing or doesn’t work properly, triglycerides build up in the blood to very high levels.
Redemplo works by lowering levels of a protein called APOC3, which is mainly made in the liver. APOC3 slows the body’s ability to remove triglycerides from the blood. By reducing APOC3 in people with FCS, Redemplo helps the body clear triglycerides more effectively, leading to lower triglyceride levels in the blood.
Lower blood triglyceride levels are expected to reduce the risk of serious complications in people with FCS.
Redemplo is given as an injection under the skin (subcutaneous injection).
Why the TGA approved or did not approve this medicine
There are currently no approved treatments in Australia that effectively treat FCS.
The effectiveness and safety of Redemplo were assessed in one main clinical study called PALISADE and 2 supporting studies.
The main study included 75 adult patients with FCS who were on a low-fat diet and had very high fasting triglycerides despite standard lipid‑lowering treatment. Most of the patients (89.3%) had previously experienced pancreatitis.
The patients, aged 18 years or older, were given 4 injections every 3 months of Redemplo 25 mg, Redemplo 50 mg (not an approved dose for FCS), or placebo (a control treatment with no active medicine).
Key findings from the clinical studies
The main study showed that the recommended dose of 25mg of Redemplo significantly and consistently lowered APOC3 and triglyceride levels (measured after fasting, usually 8-12 hours without eating).
- At 10 months, all patients who received the 25 mg dose of Redemplo had lower triglyceride levels than at the start of the study. About 80% of these patients had reductions of more than 50%.
- The 50 mg dose of Redemplo did not provide any additional triglyceride‑lowering benefit compared with the recommended 25 mg dose.
- Reductions in triglyceride levels with Redemplo were seen as early as one month and were maintained throughout the study, with little variation over time.
- At several points during Redemplo treatment, triglyceride levels fell below the level linked to a higher risk of acute pancreatitis.
- The risk of acute pancreatitis was 83% lower in patients treated with Redemplo (25 mg or 50 mg), compared with placebo. Pancreatitis occurred in 4% of patients given Redemplo and 20% of patients given placebo.
Results across all 3 studies showed consistent benefits and safety findings.
- In an extension of the main study, triglyceride levels dropped quickly after patients were switched from placebo to Redemplo and stayed low for 18 months.
- The most common adverse event was hyperglycaemia (including diabetes mellitus and increased blood glucose). Hyperglycaemic events were reported in 12.8% of patients treated with Redemplo compared with 9.8% on placebo, but very few patients (0.68%) stopped Redemplo treatment because of hyperglycaemia.
- Other common adverse events were headache and injection site reaction (redness, pain, itching, or other mild reactions where the injection was given).
The TGA decided that the application provided sufficient evidence supporting the safety and effectiveness of Redemplo and the medicine can be registered in Australia.
More detailed information on why the TGA approved Redemplo will be published in the upcoming Australian Public Assessment Report (AusPAR).
For comprehensive information on potential side effects and risks, refer to the Consumer Medicine Information (CMI) leaflet or Product Information (PI) document.
This decision summary will not be updated to reflect any subsequent changes and may not contain the most current information about the medicine. For the latest information, refer to the medicine’s CMI or PI.
Consumer Medicine Information (CMI)
The CMI leaflet offers guidance for consumers to support safe and effective use of the medicine. The CMI includes information on dose, how to use the medicine properly, potential side effects, safety precautions, storage instructions and more.
The Australian CMI for Redemplo can be accessed through the searchable TGA eBusiness Services or ARTG databases.
Product Information (PI)
The PI document provides essential prescribing information for health professionals, including details on dosage recommendations, pregnancy category, contraindications, precautions and potential side effects.
The Australian PI for Redemplo can be accessed through the searchable TGA eBusiness Services or ARTG databases.
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Other resources
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