What Is Redemplo, and Why Does It Matter?
Redemplo (plozasiran) is a type of medicine called a small interfering RNA (siRNA) therapy approved to help lower extremely high triglyceride levels in adults with familial chylomicronemia syndrome (FCS) or ongoing chylomicronemia. This medicine works by blocking a liver protein called apolipoprotein C-III (APOC-III), which normally raises triglyceride levels. By reducing this protein, Redemplo helps your body clear fat from the blood more effectively, which may lower the risk of serious problems like pancreatitis.
FCS is a rare inherited condition that causes extremely high levels of triglycerides, even when fasting. These high levels can lead to repeated episodes of acute pancreatitis, a painful and sometimes dangerous inflammation of the pancreas. People with FCS may also deal with ongoing belly pain, tiredness, and a lower quality of life. Current treatments, like strict low-fat diets and standard triglyceride-lowering medicines, often don’t work well enough to prevent these complications.
Its approval gives a new option to the estimated 6,500 people in the U.S. living with this hard-to-treat condition, especially those who haven’t had success with other therapies.
Why Was It Approved?
Redemplo was approved because studies showed it helped lower triglyceride levels and may reduce the risk of pancreatitis in adults with ongoing chylomicronemia, including those with FCS. In one study, people received either Redemplo every three months or a placebo. After 10 months, those taking Redemplo had a much greater drop in triglyceride levels compared to those taking the placebo.
The medicine also appeared to lower the chance of having a new episode of acute pancreatitis. Only 4% of people taking Redemplo had a new case, compared to 20% of those taking the placebo. This suggests that Redemplo may help prevent serious complications linked to high triglycerides.
The most common side effects were stomach pain, headache, nausea, cold-like symptoms, and reactions where the needle entered the skin. Some people with diabetes or prediabetes had small increases in blood sugar levels. Mild changes in liver enzyme levels were also seen, but none were considered serious.
What Do I Need to Know?
Redemplo is given as a shot under the skin once every three months. You or a caregiver can inject it into your thigh or belly. A health care provider or caregiver can also give it in your upper arm. While using Redemplo, you’ll need to follow a strict low-fat diet — no more than 20 grams of fat per day.
If you miss a dose, take it as soon as you remember, then continue with the three-month schedule from that date. Redemplo is expected to be available in the U.S. before the end of the year.
This medicine hasn’t been studied in children, people with uncontrolled diabetes, or those with serious kidney problems. If you have diabetes or prediabetes, your health care provider may want to check your blood sugar more often. Liver tests may also be done during treatment to monitor for any changes.
There are no known drug interactions or specific safety warnings listed in the prescribing information. Still, talk to your health care provider if you have liver or kidney issues, are pregnant, or are breastfeeding.