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Adults on Redemplo® saw steep reductions in triglycerides
The safety and effectiveness of Redemplo were studied in PALISADE—a double-blind, randomized, placebo-controlled clinical study in 75 adult patients with genetically confirmed or clinically diagnosed FCS, in combination with a low-fat diet (≤20 grams of fat per day).
A new starts now—Adults on Redemplo saw an 80% reduction in triglycerides from baseline at Month 10
Percent Change Collapse
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Sustained Triglyceride Reductions With Redemplo 25 mg*
Absolute Values Collapse
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Sustained Triglyceride Reductions With Redemplo 25 mg*
Over the 12-month study period, Redemplo was shown to consistently lower triglyceride levels with just one dose every 3 months.
*Median fasting triglycerides at baseline were 2008 mg/dL for Redemplo (n=26) and 2053 mg/dL for placebo (n=25).
†Redemplo 25 mg reduced median triglycerides by 80% (from 2008 mg/dL to 443 mg/dL) at Month 10 compared with 17% for placebo (from 2053 mg/dL to 1614 mg/dL).
Fewer people taking Redemplo had acute pancreatitis attacks compared with placebo‡
‡The clinical study included an evaluation of acute pancreatitis events that occurred in patients taking Redemplo compared to those taking placebo. Redemplo has not been proven to reduce acute pancreatitis events.
All patients taking Redemplo saw reductions in triglyceride levels§
Expert guidelines support lowering triglycerides below 500 mg/dL to reduce the risk of acute pancreatitis
§Only included patients who had fasting triglyceride measurements at Month 10. Redemplo (n=24); placebo (n=19).
How was Redemplo studied?
The safety and effectiveness of Redemplo were studied in PALISADE—a double-blind, randomized, clinical study in 75 adult patients with genetically confirmed or clinically diagnosed FCS, in combination with a low-fat diet (≤20 grams of fat per day). The main goal of the trial was to examine how much Redemplo lowered triglycerides from the start of the trial to Month 10 compared with placebo.
STUDY DESIGN Collapse
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75 adults with FCS received an injection under the skin once every 3 months
Some received plozasiran# at 1 of 2 dose levels, and others received a placebo (a treatment with no active medicine)
In addition to the main goal above, researchers also evaluated triglyceride levels at 12 months, levels of a protein called APOC3,** and whether participants had any pancreatitis attacks during the study
#Plozasiran is the active ingredient in Redemplo. In the clinical study, 25-mg and 50-mg doses of plozasiran resulted in similar triglyceride reductions. The 50-mg dose is not an approved dosing regimen.
**A protein the liver creates which slows the breakdown and removal of triglyceride-rich particles (fat particles) from the bloodstream. Think of APOC3 as a “speed bump” that slows down how quickly the body can clear these fat particles.
INCLUSION CRITERIA Collapse
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Patients were included in this study if they were 18 years or older with:
Fasting triglyceride levels of 880 mg/dL or more††
and at least ONE of the following:
Recurrent acute pancreatitis attacks‡‡
Hospitalizations for severe stomach pain without any reason
History of childhood pancreatitis
Family history of acute pancreatitis caused by HTG
Prior genetic confirmation of FCS
††In excess of 1000 mg/dL at least 3 times; does not respond well to lipid-lowering therapy.
‡‡Not caused by alcohol or gallstones.
BASELINE CHARACTERISTICS Collapse
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| Baseline Characteristics | |
|---|---|
| Median triglycerides | 2030 mg/dL |
| Mean age | 46 years |
| Diabetes | 24% |
| History of pancreatitis | 61% |
| Clinically diagnosed | 49% |
| Genetically confirmed | 51% |
| Gender | |
|---|---|
| Male | 49% |
| Female | 51% |
| Race | |
|---|---|
| White | 73% |
| Asian | 21% |
| Other | 5% |
| Ethnicity | |
|---|---|
| Hispanic or Latino | 3% |
APOC3, apolipoprotein C-III; FCS, Familial Chylomicronemia Syndrome; HTG, hypertriglyceridemia.
Indication & Important Safety Information
Indication
REDEMPLO® (plozasiran) is an injectable prescription medicine used together with a low-fat diet to reduce triglycerides (fat in the blood) in adults with a condition that keeps the body from breaking down fats called familial chylomicronemia syndrome (FCS).
Important Safety Information
Before you start using REDEMPLO, tell your healthcare provider about all your medical conditions, including if you are pregnant or plan to become pregnant, or are breastfeeding or plan to breastfeed. It is not known if REDEMPLO could harm your unborn baby, or if it passes into your breast milk and could harm your breastfeeding baby.
Tell your healthcare provider or pharmacist about any prescription and over-the-counter medicines, vitamins, or herbal supplements you take.
What are the possible side effects of REDEMPLO?
The most common side effects of REDEMPLO include increased blood sugar levels, headache, nausea, and injection site reactions (pain, redness, or swelling).
These are not all the possible side effects of REDEMPLO. Tell your healthcare provider or treatment team if you have any side effect that bothers you or that does not go away.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/safety/medwatch, or call 1-800-FDA-1088.