Following the release of positive Phase IIb results, Arrowhead Pharmaceuticals’ investigational antisense oligonucleotide plozasiran could rake in more than $700 million in sales by 2032 if it wins the FDA’s approval, according to a new report from data analytics firm GlobalData.
Plozasiran’s approval could also help satisfy a critical unmet medical need in dyslipidemia management and provide a treatment option that can “effectively lower triglyceride levels and prevent the complications associated with this disease,” Shireen Mohammad, cardiovascular and metabolic disorders analyst at GlobalData, said in a statement.
“Plozasiran offers hope for the dyslipidemia drug market,” Mohammad added. “According to GlobalData, plozasiran is forecasted to launch in 2026 and is a promising pipeline drug for the treatment of dyslipidemia.” If approved, the treatment could generate $707 million in sales for Arrowhead by 2032.
An investigational antisense RNA interference therapeutic, plozasiran works by targeting the liver protein ApoC3, which is a crucial player in lipid metabolism and also controls the levels of triglycerides in the blood. In dyslipidemia ApoC3 prevents the clearance of various lipids and lipoproteins from the body.
According to Arrowhead’s website, plozasiran’s mechanism of action allows it to disrupt the pathologic role of ApoC3, in turn normalizing lipid levels in patients and lowering their overall risk for cardiovascular diseases.
Earlier this month, at the American College of Cardiology’s 73rd Annual Scientific Session & Expo, Arrowhead presented data from the Phase IIb SHASTA-2 trial, showing that patients in the plozasiran arm saw a 74% decrease in triglyceride levels, while placebo comparators only showed a 17% reduction at 24 weeks.
At 48 weeks, plozasiran elicited a 58% drop in triglyceride levels, compared to only 7% in the placebo group.
ApoC3 levels also decreased by 48% after plozasiran treatment at 48 weeks. Placebo counterparts, on the other hand, saw a 4% increase in ApoC3.
In addition to SHASTA-2, Arrowhead is also running the Phase III PALISADE trial for plozasiran, evaluating its efficacy in FCS. The study completed enrollment in May 2023 and the company expects its primary portion to be completed by the second quarter of 2024. Readouts and regulatory filings will follow “shortly thereafter,” Arrowhead announced at the time.
In March 2023, the FDA granted plozasiran its Fast Track designation for the treatment of FCS, which will accelerate its review process and will allow the company more frequent interactions with the FDA. Plozasiran had previously earned the regulator’s Orphan Drug designation.
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