MSD announced on July 16 that the US Food and Drug Administration approved the marketing of the oral PCSK9 inhibitor LIPFENDRA to treat adult hypercholesterolemia, including heterozygous familial hypercholesterolemia. This drug is the first FDA-approved oral PCSK9 inhibitor. The phase III CoralReef Lipids trial showed that LDL cholesterol was reduced by 56% compared to placebo after 24 weeks of LIPFENDRA treatment; the decrease in the CoralReef HEFH trial was 59%. The company said that research on cardiovascular outcomes is still ongoing, and it has not been proven that the drug can reduce the risk of cardiovascular events.
Zhitongcaijing · 1d ago
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MSD announced on July 16 that the US Food and Drug Administration approved the marketing of the oral PCSK9 inhibitor LIPFENDRA to treat adult hypercholesterolemia, including heterozygous familial hypercholesterolemia. This drug is the first FDA-approved oral PCSK9 inhibitor. The phase III CoralReef Lipids trial showed that LDL cholesterol was reduced by 56% compared to placebo after 24 weeks of LIPFENDRA treatment; the decrease in the CoralReef HEFH trial was 59%. The company said that research on cardiovascular outcomes is still ongoing, and it has not been proven that the drug can reduce the risk of cardiovascular events.
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