Ionis Pharmaceuticals recently announced that the U.S. FDA has approved, under Priority Review, a supplemental New Drug Application (sNDA) for its antisense oligonucleotide (ASO) therapy, Olezarsen. The approval is for reducing triglyceride (TG) levels and the risk of acute pancreatitis in adults with severe hypertriglyceridemia (sHTG).
Olezarsen is available in two doses, 50 mg and 80 mg, administered once monthly via an autoinjector. sHTG, defined as serum triglyceride levels ≥500 mg/dL, is a serious condition with a primary risk of acute pancreatitis, a medical emergency that can cause severe abdominal pain, prolonged hospitalization, and irreversible organ damage. Current standard treatments, including lifestyle modifications, often fail to adequately control TG levels in all patients, leaving a significant unmet medical need.
As a novel GalNAc-conjugated ASO, Olezarsen targets apolipoprotein C-III (APOC3), a key protein that regulates triglyceride metabolism by inhibiting lipoprotein lipase activity and hepatic uptake of triglyceride-rich lipoproteins. By inhibiting APOC3 gene expression, Olezarsen enhances lipid clearance, thereby reducing both triglyceride levels and the risk of pancreatitis.
The approval is supported by positive data from the global Phase III CORE and CORE2 trials, published in the New England Journal of Medicine. These studies evaluated adults with sHTG (TG ≥500 mg/dL). The results showed that after 6 months, triglycerides were reduced by 63% (50 mg) and 72% (80 mg) in CORE, and by 49% and 55% in CORE2, with effects sustained through 12 months. Importantly, Olezarsen reduced the incidence of acute pancreatitis by up to 91%. In patients with 12-month data, 86% achieved TG levels below 500 mg/dL, a key threshold for lowering pancreatitis risk. The safety profile was generally well-tolerated, with comparable rates of adverse events across treatment and placebo groups.
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