Clinical Trials
1
0 active
Approvals
0
Total approvals
Agencies
0
Regulatory bodies
Founded
N/A
No trial phase data available
Recruiting
1
100.0%
No approval data available
- The US FDA has approved Juxtapid (lomitapide) capsules for pediatric use in homozygous familial hypercholesterolemia (HoFH) for children 2 years of age and older, expanding access to a proven therapy previously available only for adults. - A Phase 3 study demonstrated a mean 49% reduction in LDL cholesterol levels in 43 pediatric participants aged 5-17 years with HoFH over a 24-week treatment period. - HoFH is an ultra-rare genetic disorder affecting 1 in 250,000 to 1 in 360,000 individuals worldwide, causing dangerously high cholesterol levels from birth and significantly increased risk of severe atherosclerosis without early intervention.
- The VESALIUS-REAL study of 278,000 high-risk patients found 70% did not receive lipid-lowering therapy after heart attacks or strokes, and 88% had no treatment intensification within a year. - Half of cardiovascular event patients never received follow-up LDL-C testing, and among those tested, 82% failed to achieve guideline-recommended cholesterol goals despite available treatments. - Amgen is working to address these care gaps through initiatives including free LDL-C testing at CVS MinuteClinics, partnerships with cardiology organizations, and the LATTICE Consortium to accelerate implementation science.
- A landmark study of over 273,000 individuals with atherosclerotic cardiovascular disease found that every increase in lipoprotein(a) levels is associated with higher risk of recurrent cardiovascular events. - Patients with very high Lp(a) levels (≥300 nmol/L) faced a 45% increased risk of subsequent cardiovascular events compared to those with low levels (<15 nmol/L), with slightly higher risks observed in Hispanic and Black individuals. - High-impact LDL cholesterol-lowering therapies, particularly PCSK9 inhibitors, may help mitigate the harmful effects of elevated Lp(a) levels, suggesting important treatment implications for high-risk patients.
- The Family Heart Foundation has introduced Cholesterol Connect, offering free at-home lipid screening and personalized support to address cardiovascular disease, which claims one American life every 33 seconds. - The program, sponsored by Amgen, provides comprehensive testing for total cholesterol, LDL-C, HDL-C, triglycerides, and Lp(a), with 71 million Americans having high LDL-C but 40% unaware of their condition. - Participants receive access to virtual consultations with Care Navigators, educational resources, and secure result sharing capabilities, regardless of insurance status.
