- Esperion Therapeutics Inc's 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.
No comments:
Post a Comment
Note: Only a member of this blog may post a comment.