MHRA authorises plozasiran for adults with familial chylomicronaemia syndrome
On 19 October 2026, the Medicines and Healthcare products Regulatory Agency authorised plozasiran, sold under the brand name Redemplo, for adults with familial chylomicronaemia syndrome. Familial chylomicronaemia syndrome is a rare condition that causes high levels of fats called triglycerides in the blood, which can lead to severe abdominal pain from inflammation of the pancreas. Plozasiran works by blocking apolipoprotein C3, a liver protein that slows fat breakdown. It is given as a 25 mg injection under the skin every three months, which trained patients or caregivers can administer themselves. Approval was based on a clinical trial of 75 adults following a controlled diet. After 10 months, people taking plozasiran had a median triglyceride reduction of about 80%, compared to 17% for those on a placebo. The study also recorded fewer episodes of acute pancreatitis in the plozasiran group. Hyperglycaemia is the most common side effect, affecting more than one in 10 patients.
What was announced
The Medicines and Healthcare products Regulatory Agency (MHRA) authorised plozasiran (Redemplo) on 19 October 2026. The approval allows the drug to be used alongside a low-fat diet to lower blood fat levels in adults with familial chylomicronaemia syndrome (FCS).
The agency evaluated a trial of 75 adults with FCS who were on controlled diets. In that study, 50 adults received plozasiran and 25 received a placebo. After 10 months, patients taking plozasiran showed a median triglyceride reduction of about 80 per cent, while those on placebo saw a 17 per cent reduction. Participants using the drug experienced fewer acute pancreatitis attacks.
The authorisation was granted to Arrowhead Pharmaceuticals Ireland Limited using Route B of the International Recognition Procedure. The European Medicines Agency served as the reference regulator.
What it means
Adults diagnosed with FCS have a new regulated treatment option in the UK. The drug targets apolipoprotein C3, a liver protein that normally slows how the body breaks down fats. By blocking this protein, plozasiran helps lower triglyceride concentration in the blood.
Patients can administer the treatment as a 25 mg injection beneath the skin once every three months, provided they or their caregivers complete training. It must be taken alongside a low-fat diet.
The regulator noted potential side effects. Raised blood sugar, known as hyperglycaemia, may affect more than one in 10 patients. Up to one in 10 patients may experience headaches, nausea, or reactions at the injection site. The MHRA stated it will monitor the safety of the drug and asked patients to submit reports of suspected side effects through its Yellow Card scheme.
What the announcement does not tell us
The announcement does not state when plozasiran will become available to NHS patients or what it will cost. It does not mention whether the drug will be accessible in pharmacy outlets or require a hospital prescription.
The release does not explain if the treatment is safe or approved for children or pregnant women. Furthermore, the MHRA did not provide the precise number of pancreatitis episodes recorded during the 10-month trial.
How this was written
This analysis was written with AI from the official announcement below, using only facts that announcement states. The quoted wording is gov.uk: Medicines and Healthcare products Regulatory Agency’s own. Always check the original before acting on anything here.
The Medicines and Healthcare products Regulatory Agency (MHRA) has today, 19 October 2026, authorised plozasiran (Redemplo)
Opens www.gov.uk
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