MHRA authorises plozasiran (Redemplo) for adults with familial chylomicronaemia syndrome
The Medicines and Healthcare products Regulatory Agency (MHRA) has today, 19 October 2026, authorised plozasiran (Redemplo)
The Medicines and Healthcare products Regulatory Agency (MHRA) has today, 19 October 2026, authorised plozasiran (Redemplo) to reduce triglyceride levels in adults with familial chylomicronaemia syndrome (FCS), alongside a low-fat diet.
FCS is a rare condition that causes abnormally high levels of fats called triglycerides in the blood. This can lead to inflammation of the pancreas, known as pancreatitis, causing severe abdominal pain.
Plozasiran blocks the production of apolipoprotein C3, a protein made in the liver that slows the breakdown of fats. Reducing production of this protein helps lower triglyceride levels in the blood.
The medicine is administered as a 25 mg injection under the skin once every three months. Patients or their caregivers can give the injection after receiving training.
Julian Beach, Executive Director, Operations, said:
“This authorisation provides an additional treatment option for adults with familial chylomicronaemia syndrome, a rare condition that can cause serious and painful complications.
“Clinical trial data showed that plozasiran substantially reduced triglyceride levels when used alongside a controlled diet.
“As with all medicines, we will continue to monitor the safety of plozasiran closely.”
The authorisation is supported by a main study involving 75 adults with FCS. All participants followed a controlled diet, with 50 receiving plozasiran and 25 receiving placebo.
After 10 months, participants receiving plozasiran had a median reduction in triglyceride levels of around 80%, compared with 17% among those receiving placebo. The study also recorded fewer episodes of acute pancreatitis in participants receiving plozasiran.
The most common side effect reported with plozasiran is hyperglycaemia (raised blood sugar), which may affect more than one in 10 people. Other common side effects, which may affect up to one in 10 people, include headache, nausea and reactions at the injection site.
Anyone who suspects they are experiencing a side effect should speak to their doctor, pharmacist or nurse and report it directly through the Yellow Card scheme at https://yellowcard.mhra.gov.uk or via the MHRA Yellow Card app.
Notes to editors
-
The marketing authorisation was granted on 19 October 2026 to Arrowhead Pharmaceuticals Ireland Limited.
-
It was approved through the International Recognition Procedure (IRP), Route B, with the European Medicines Agency (EMA) as the reference regulator.
-
More information can be found in the Summary of Product Characteristics (SmPC) and Patient Information Leaflet (PIL), which will be published on the MHRA Products website in due course.
-
The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe. All our work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks.
-
The MHRA is an executive agency of the Department of Health and Social Care.
-
For media enquiries, please contact newscentre@mhra.gov.uk, or call 020 3080 7651.