Waylivra (volanesorsen), an additional apoCII inhibitor, is marketed by Ionis in the EU for patients with FCS who have not responded adequately to previous TG-lipid lowering treatments including statins and ezetimibe.
Olezarsen from Ionis Pharmaceuticals, according to data and analytics firm GlobalData, has the potential to fill a gap in the market for more effective triglyceride lipid-lowering treatments.
Ionis Pharmaceuticals’ experimental treatment, olezarsen, for people with familial chylomicronemia syndrome recently gained US FDA Fast Track classification (FCS).
In the meantime, Olezarsen is also being researched in the US and other EU nations, including France, Germany, Italy, and the UK, for severe hypertriglyceridemia (sHTG). If authorised, it could satisfy a gap in the market for more potent triglyceride lipid-lowering treatments, according to GlobalData.
High-fat diets and sedentary lifestyles are two environmental factors that might cause sHTG, which frequently develops as a byproduct of FCS. Triglyceride levels are significantly raised in sHTG, which raises the danger of atherosclerotic cardiovascular disease and mortality. According to Kaya Olczak, a healthcare analyst at GlobalData, “Olezarsen is an antisense RNA oligonucleotide that suppresses the hepatic production of apoCII, improving clearance, lowering triglyceride serum levels, and reducing the risk of atherosclerosis.
Waylivra (volanesorsen), an additional apoCII inhibitor, is marketed by Ionis in the EU for patients with FCS who have not responded adequately to previous TG-lipid lowering treatments including statins and ezetimibe.
The FDA denied Waylivra certification for FCS in the US in 2018, hence Ionis is celebrating this Fast Track designation for olezarsen in FCS. The possibility of the FDA approving olezarsen for sHTG has increased to 72%, according to GlobalData’s Pharma Intelligence Center, the company claims.
Both Waylivra and Olezarsen are being studied for sHTG, and according to GlobalData, if Phase III clinical studies are successful, both treatments might be made available to sHTG patients as early as 2028 in the US and the EU. Waylivra and olezarsen’s further approval for sHTG will boost Ionis’ dyslipidemia portfolio and its competitive position in the dyslipidemia market, Olczak continued.
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