The Food and Drug Administration (FDA) has approved Nexletol (bempedoic acid; Esperion) as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia (HeFH) or established atherosclerotic cardiovascular disease (ASCVD) who require additional lowering of low-density lipoprotein cholesterol (LDL-C). Nexletol is a first-in-class adenosine triphosphate-citrate lyase (ACL)…
The primary end point was radiographic progression-free survival (rPFS), defined as the time from randomization to radiographic disease progression at any time or death within 24 weeks after drug discontinuation.
The agency alleges manufacturers failed to provide evidence of the long-term safety of surgical mesh for transvaginal repair of anterior compartment prolapse.
