FDA Expands Amgen's Repatha for Primary Prevention of Heart Disease
Amgen's cholesterol-lowering drug Repatha has received a significant boost. The FDA has approved it for primary prevention of cardiovascular disease, expanding its use beyond patients already diagnosed with the condition.
The decision follows the successful completion of the Phase III VESALIUS-CV trial, involving over 12,300 patients. For a median of 4.5 years, Repatha demonstrated a 'statistically and clinically significant' reduction in heart complications. This included a lower risk of heart attack, ischemic stroke, and death from coronary heart disease.
Amgen reported no new safety signals of concern from the trial. Analysts now suggest the formal label expansion should help drive broader adoption of Repatha for primary prevention, potentially benefiting a larger patient population.
The FDA's approval of Repatha for primary prevention marks a significant milestone. It opens up the drug's benefits to high-risk patients without a prior cardiovascular disease diagnosis. Amgen's PCSK9 blocker continues to show promise in preventing heart complications.
