Amgen says FDA broadens the approved use of Repatha

Amgen (AMGN) announced that the U.S. FDA has broadened the approved use of Repatha to include adults at increased risk for major adverse cardiovascular events due to uncontrolled low-density lipoprotein cholesterol, commonly known as ‘bad cholesterol.’ The update removes a prior requirement for a patient to have been diagnosed with cardiovascular disease. In addition to expanding Repatha’s label to include adults at increased risk of MACE, the FDA also: Expanded the use of Repatha alone (monotherapy) to include patients with a rare, genetic form of high cholesterol known as homozygous familial hypercholesterolemia; and emphasized that Repatha should be used alongside diet and exercise for managing high cholesterol.