Shots:
- The US FDA has approved Lipfendra (20mg, PO) as an adjunct to lifestyle intervention to reduce LDL-C in adults with hypercholesterolemia, incl. HeFH, based on 2 P-III trials (CORALreef Lipids & CORALreef HeFH) assessing it vs PBO
- At Wk. 24 in Lipids trial, Lipfendra reduced LDL-C by 57% vs a 3% increase from baseline, with a 56% PBO-adjusted reduction. Post-hoc data showed a 60% vs 3% LDL-C reduction after excl. LDL-C values ≤0. It also reduced non-HDL-C by 54% & ApoB by 50%
- At Wk. 24 in HeFH trial, Lipfendra reduced LDL-C by 58% from baseline vs a 3% increase, with a 59% PBO-adjusted reduction. Lipfendra also reduced non-HDL-C by 52% & ApoB by 48%, vs a 2% increase
Ref: Merck | Image: Merck | Press Release
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