The UK National Institute for Health and Care Excellence (NICE) has granted Technology Appraisal Guidance (TAG) for French pharmaceutical company Sanofi's latest cholesterol-lowering treatment, Praluent (alirocumab).
The National Health Service (NHS) has 90 days to make alirocumab available across England and Wales as a treatment option for people with high levels of bad cholesterol or low-density lipoprotein cholesterol (LDL-C) and who are at a high risk of a heart attack or stroke.
The product was co-developed by Sanofi and US-based biotechnology company Regeneron.
Sanofi cardiovascular division director Dr Tunde Falode said: "Sanofi is delighted that Praluent will shortly be available on the NHS for people living with the risk of raised cholesterol levels.
"At Sanofi we have worked closely with NICE to address the unmet clinical needs of patients at high risk of cardiovascular disease and we are committed to ensuring that these patients have access to this innovative treatment as soon as possible."
The current guidance will help several people in the UK who are unable to control their high cholesterol levels, despite following a diet and taking the maximum tolerated dose of statins and other lipid-lowering therapies.
These patients include those who have high levels of LDL cholesterol, which is an inherited form of high cholesterol levels (heterozygous familial hypercholesterolaemia), and patients who are statin intolerant, or contraindicated.
Alirocumab is the only PCSK9 inhibitor, available in two starting strengths including 75mg and 150mg.
Sanofi has additionally launched MyPraluent Coach, which is a free, flexible programme offering one-to-one home nurse support, text message injection reminders and materials to better patients' knowledge of their condition.