Esperion Therapeutics Inc's (NASDAQ: ESPR) CLEAR Outcomes trial met its primary endpoint, demonstrating statistically significant risk reduction in MACE-4 in patients treated with 180 mg/day NEXLETOL (bempedoic acid) compared to placebo.
The data demonstrate statistically significant and clinically meaningful results.
The study included over 14,000 patients at over 1,200 sites in 32 countries.
Bempedoic acid becomes the first ATP citrate lyase inhibitor and oral non-statin to meet the major adverse cardiovascular events (MACE-4) primary endpoint.
NEXLETOL is indicated as an adjunct to diet and maximally tolerated statin therapy for heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease who require additional lowering of LDL-C.
The company reported CLEAR Outcomes trial data sooner than expected in January 2023.
In Q3, NEXLETOL generated sales of $14 million, up 28% Y/Y.
The company looks forward to sharing this data with the medical community and submitting it to appropriate regulatory authorities as quickly as possible in 2023.
Price Action: ESPR shares are up 2.55% at $7.25 on the last check Wednesday.
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