FDA says PCSK9 inhibitors may not require outcome studies

The US Food and Drug Administration has said that pharma companies developing  PCSK9 inhibitors will not be required to provide results from outcomes studies before they are approved.

Bloomberg has reported that the US FDA says the PCSK9 inhibitors will only have to meet the agency’s existing standards for clearance, which includes whether they cut cholesterol and reduce blood pressure or inflammation.

The information follows new clinical guidelines last week for the treatment of cholesterol in people at high risk of cardiovascular disease from the American College of Cardiology (ACC) and the American Heart Association (AHA).