We have some exciting news for people living with pancreatitis caused by the FCS genetic mutation. The FDA has approved REDEMPLO® (plozasiran), a new treatment from Arrowhead Pharmaceuticals that lowers triglycerides and reduces acute pancreatitis attacks in adults with Familial Chylomicronemia Syndrome (FCS).
This is an important step for people with FCS and a meaningful milestone for the broader pancreatitis community. Two forms of pancreatitis now have FDA-approved treatment options: autoimmune pancreatitis caused by IgG4-related disease and high-triglyceride pancreatitis resulting from FCS.
This is the second medication the FDA has approved for FCS. (See our blog on Ionis Pharmaceuticals’s new FCS therapy here.)
What is Familial Chylomicronemia Syndrome (FCS)?
FCS is a rare genetic condition that makes it very hard for the body to break down fats (triglycerides) in the blood. This leads to extremely high triglyceride levels, which can cause:
- Severe stomach pain
- Frequent hospitalizations
- Life-threatening attacks of acute pancreatitis
Although FCS affects about 3,000 people in the U.S., it has a serious impact on those who live with it.
This condition is also known as lipoprotein lipase deficiency (LPLD) or familial hypertriglyceridemia and is a rare genetic form of severe hypertriglyceridemia (sHTG).
Learn more about High Triglycerides, FCS, and Pancreatitis
- Watch our High Triglycerides Webinar with Dr. Andres Gelrud
- Read about Triglycerides and FCS
- Access a Peer Support Resource for Managing FCS
How Does This Treatment Work?
This newly approved treatment lowers APOC3, a protein that plays a key role in regulating fat (triglyceride) levels in the blood.Â
By reducing APOC3, the drug helps decrease triglycerides and lower the risk of acute pancreatitis attacks in people with FCS
Key things to know:
- It is taken once every three months
- It can be self-injected at home
- It is approved along with a low-fat diet
What Did the Study Show?
In the Phase 3 PALISADE study, adults with FCS who took REDEMPLO saw:
- An 80% drop in triglycerides (compared to 17% with placebo)
- Fewer pancreatitis attacks
Common side effects included headache, nausea, and injection-site reactions.
Why Does This Matter for the Greater Pancreatitis Community?
Even if you don’t have FCS, this approval is encouraging news for the entire pancreatitis community.
- It opens the door for new pancreatitis treatments. As recently as November 2024, there were no FDA-approved drug to reduce pancreatitis attacks. Having a treatment for FCS shows that targeting triglycerides can help prevent pancreatitis, which helps encourage more research into treatments for other causes of the disease.
- It strengthens the case for genetic testing. Now that a treatment exists for a genetic cause of pancreatitis, doctors may be more likely to recommend genetic testing for people with unexplained or recurrent pancreatitis.
- It brings more attention and investment to pancreatitis research. Each successful approval helps show that pancreatitis treatments are possible.
For more details, you can read the official press release from arrowhead here.
Looking Ahead
Arrowhead expects REDEMPLO to be available in the U.S. before the end of the year. They’re also offering a patient support program, Rely On REDEMPLO, to provide support services and resources for patients at each stage of the treatment journey.
On Dec. 2, 2025, Arrowhead announced that the FDA granted the Breakthrough Therapy designation to plozasiran for severe hypertriglyceridemia (sHTG). Â
This designation is given to drugs that treat serious conditions and show early signs of working better than current options. It’s meant to speed up the development and review process so patients can get access to promising therapies sooner.
For the pancreatitis community, this progress is encouraging. Multiple therapies moving through this pathway shows growing investment in solutions that could benefit a wider portion of our community.Â
At Mission: Cure, we will keep working to accelerate treatments and improve care for everyone living with pancreatitis.
About Mission: Cure
At Mission: Cure, we are dedicated to finding effective treatments and, ultimately, a cure for pancreatitis. Through patient education, research, and advocacy, we strive to improve the lives of those affected by this condition.
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