Merck's Lipfendra Pill Gets FDA Approval for High-Risk Cholesterol Patients

The FDA has approved Merck's new pill, Lipfendra, to help reduce cholesterol levels in high-risk patients. This is the first non-injectable medication that targets a liver protein called PCSK9, which limits the body's ability to clear cholesterol from the blood.

Lipfendra works by blocking this protein, and has been shown to be effective in two studies involving 3,000 high-risk patients. In one study, those taking Lipfendra saw their LDL cholesterol levels drop by more than 55% after six months. The benefit of the pill was maintained over a year, with side effects similar to those experienced by patients taking a dummy pill.

The FDA approved Lipfendra under its ultra-fast review program for promising medications that serve the public interest. This approval is significant because heart disease is the nation's leading cause of death, and high LDL cholesterol is a major risk factor for heart attacks and strokes.