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.