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news.The US Food and Drug Administration (FDA) has expanded the use of Amgen’s Repatha (evolocumab) to include adults who are at high risk for major adverse cardiovascular events (MACE) due to uncontrolled low-density lipoprotein cholesterol (LDL-C).
The update eliminates the previous requirement for a cardiovascular disease diagnosis prior to treatment. Credit: Robina Weermeijer on Unsplash.
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This change eliminates the previous requirement for a cardiovascular disease diagnosis prior to treatment.
Amgen global commercial operations executive vice president Murdo Gordon said: “Far too many adults at risk of cardiovascular disease are not achieving their LDL-C goals, despite it being one of the most modifiable risk factors for a heart attack or stroke.
“This label update highlights the real-world need for additional treatment options for at-risk patients. Repatha is an effective therapy for reducing LDL-C, particularly in patients whose disease remains uncontrolled with statins or who cannot tolerate them.”
In addition to broadening Repatha’s label, the FDA has extended approval for the therapy as a single agent to include individuals with homozygous familial hypercholesterolaemia (HoFH), a rare genetic high cholesterol form.
The regulator emphasised that Repatha should continue to be used in conjunction with diet and exercise for high cholesterol management.
Repatha is a human monoclonal antibody and was initially approved in 2015 and, according to the company, has since been utilised by over five million people globally.
It inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9) and attaches to PCSK9 and prevents it from binding to the low-density lipoprotein receptor (LDLR).
The therapy’s clinical profile has been researched over a period of 15 years through 50 trials involving over 57,000 subjects.
Repatha received approval in more than 74 countries, including Japan, the US, Canada, and all 28 EU member states.
