Source: Fortune
Summary
The FDA has approved Merck’s cholesterol-lowering pill, Lipfendra, for patients with artery-clogging cholesterol that persists despite taking statins. The pill works by blocking a liver protein called PCSK9, previously targeted by injectable biotech drugs. In two studies, patients taking Lipfendra saw their LDL cholesterol levels drop by 55% and 59% after six months. The pill must be taken on an empty stomach and has side effects similar to a placebo.
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The strategy enters a familiar phase.
Merck’s Lipfendra is the first noninjectable medication to block PCSK9, a protein limiting the body’s ability to clear cholesterol from the blood. The pill’s approval is a significant development for patients with high cholesterol, as injectable biotech drugs targeting PCSK9 have been available for over a decade but have been limited by high prices and insurance restrictions. The FDA’s fast-track review program, created by former chief Dr. Marty Makary, expedited the approval process. Merck’s pill has shown promising results in reducing LDL cholesterol levels, but its impact on heart disease and stroke risk remains to be seen.
The numbers tell a story of unmet need: high LDL cholesterol is a top risk factor for heart attacks and strokes, and current treatments often fall short.
Author: Evan Null
