Merck cholesterol pill Lipfendra is approved by FDA

Key Points:

• The FDA has approved Merck's Lipfendra, the first oral pill that significantly lowers cholesterol by blocking the liver protein PCSK9, previously targeted only by expensive injectable drugs.
• Lipfendra is intended for patients whose artery-clogging cholesterol remains high despite statin use, offering a noninvasive alternative with studies showing over 55% reduction in LDL cholesterol levels.
• Clinical trials demonstrated sustained cholesterol reduction with side effects comparable to placebo, though the pill must be taken on an empty stomach.
• The approval was expedited under the FDA's fast-track program for promising treatments, addressing a major public health concern as heart disease remains the leading cause of death in the U.S.
• This new option could improve patient access to PCSK9 inhibition, overcoming barriers posed by high costs and insurance restrictions associated with injectable alternatives.