Amgen's Repatha Recommended for Broader Use in Cardiovascular Risk Reduction
The European Medicines Agency's expert committee has issued a positive opinion recommending broader use of Amgen's Repatha to prevent the first heart attack or stroke. The recommendation follows significant risk reduction findings in clinical trials.
The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the use of Amgen's Repatha for the primary prevention of cardiovascular events, including heart attack and stroke.
This recommendation paves the way for a wider application of the drug across Europe, based on pivotal Phase III clinical trial data. The study demonstrated a statistically significant reduction in the risk of major adverse cardiovascular events for patients with elevated cholesterol and increased cardiovascular risk.
Repatha is noted as the only PCSK9 inhibitor shown in a clinical trial to significantly reduce the risk of experiencing a first heart attack or stroke. This positions the drug as establishing a new standard for cardiovascular risk reduction.
The CHMP's positive opinion is a significant step towards regulatory approval and wider patient access within the European Union. The final decision rests with the European Commission.