The Medicines and Healthcare Products Regulatory Agency has approved a new indication for MSD’s cholesterol buster Ezetrol (ezetimibe), expanding its use to include reducing the risk of cardiovascular events in certain patients.

The new indication allows doctors to prescribe the drug for patients with coronary heart disease and a history of acute coronary syndrome, when added to ongoing statin therapy or initiated concomitantly with a statin.

“This is great news particularly for our patients because many with coronary heart disease continue to have cardiovascular events, even when managed with statins at higher doses and even with conventionally ‘low’ LDL levels,” said Mark Signy, consultant cardiologist Mark Signy, who also worked on trials of the drug. 

The news comes hot on the heels of updated guidelines on Ezetrol (ezetimibe) from the National Institute for Health and Care Excellence, recommending the drug’s use on its own as an option for treating primary hypercholesterolaemia in adults who can’t take a statin, and in combination with initial statin therapy in various scenarios.

Both the updated licence and NICE guidance were based on data from the landmark IMPROVE-IT trial, which involved more than 18,000 patients and showed the drug to be the first non-statin cholesterol-lowering medication showing additional benefit in reducing the risk of CV events, according to the firm.

“The economic burden of CVD, including indirect costs from premature death and disability, is estimated to be over £15 billion each year in the UK, with more than 1.6 million episodes related to cardiovascular disease in NHS hospitals, accounting for 10% of all inpatient episodes, so any intervention which reduces that burden is significant,” said Mark Toms, executive Director of Medical Affairs, MSD UK and Ireland.