The FDA label for REDEMPLO (plozasiran) was revised effective August 25, 2026. The updated Indications and Usage section states that Redemplo is indicated as an adjunct to diet to reduce triglycerides in adults with familial chylomicronemia syndrome (FCS).
The same labeling section identifies plozasiran as an apolipoprotein C-III (apoC-III)-directed small interfering ribonucleic acid. The supplied label update concerns the indication and usage language for the product.
Background
Familial chylomicronemia syndrome is the condition named in the revised indication. The label specifies that Redemplo is used in adults with FCS and that treatment is given as an adjunct to diet. The stated treatment goal is triglyceride reduction.
Plozasiran is also identified in the supplied label text by the alias Redemplo. The label describes it as an apoC-III-directed small interfering ribonucleic acid, but the available data do not provide additional mechanism, dosing, efficacy, safety, or comparative-treatment details.
What this means
The effective change establishes the labeled use of Redemplo for adults with FCS who require triglyceride reduction alongside dietary management. It does not, in the supplied information, report a new trial result, numerical triglyceride change, comparator result, p-value, confidence interval, or adverse-event analysis.
Clinicians, researchers, and patient advocates should use the revised FDA labeling for the indication and usage language. The supplied record does not include other changes to contraindications, warnings, dosing instructions, or patient-selection criteria.
Source
Source: FDA, DailyMed drug-label document for REDEMPLO (plozasiran), with the indication and usage revision effective August 25, 2026. The document is available through dailymed.nlm.nih.gov.
