FDA approves enlicitide — the first oral PCSK9 cholesterol-lowering pill

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A long-awaited moment in preventive cardiology arrived last week, when enlicitide (which Merck is selling under the name Lipfendra) was approved by the FDA to lower blood cholesterol levels.

As the first oral PCSK9 inhibitor — powerful cholesterol-lowering medications, that, until now, have only been injectable — enlicitide itself is an impressive achievement. It punctuates a story of pharmaceutical innovation that has glided from the stories of families enrolled in the Dallas Heart Study at the bedside, to drug targets discovered at the lab bench, all ultimately transforming care back at the bedside.

It also comes at an opportune time. With new clinical guidelines supporting a more aggressive approach to lowering cholesterol levels, enlicitide may be particularly useful for people with either established or at high risk for cardiovascular disease. For the millions of Americans who fit into these groups, it has already been hailed as a game changer . But the story here — of whom it would actually help, and what it implies about prevention today — is more complicated.

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