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MHRA approves new indication for MSD’s Ezetrol

Published on 26/02/16 at 09:55am

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has approved a new indication for MSD’s Ezetrol (ezetimibe), making it available to patients with coronary heart disease (CHD) and a history of acute coronary syndrome (ACS), added to or begun alongside statin therapy. 

“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,” says Dr Mark Signy, consultant cardiologist and IMPROVE-IT investigator. “The new licence extension and updated NICE guidance reinforce the importance of ezetimibe as a useful addition to everyday treatment of cardiovascular disease, especially for those patients at higher risk.”   

NICE also separately issued its Technology Appraisal Guidance (TAG) for ezetimibe, following its Final Appraisal Determination (FAD), published in December, recommending ezetimibe as a monotherapy option for treating primary hypercholesterolaemia in adults unable to take statins; and in combination with initial statin therapy as an option when statins fail to control cholesterol levels, or when higher doses of statins are not tolerated.

People with hypercholesterolaemia have an increased risk of CHD, due to raised cholesterol levels accelerating the build-up of fatty deposits in the arteries. In the UK, one person dies from CHD about every eight minutes; making it the nation’s biggest killer.

Both the updated licence indication from MHRA, and the NICE guidance, were based on results from the 18,000-patient IMPROVE-IT trial, in which Ezetrol was shown to be the first non-statin cholesterol-lowering medication to show additional benefit in decreasing the risk of cardiovascular events when added to a statin.

“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[vi], so any intervention which reduces that burden is significant,” says Dr Mark Toms, executive director, Medical Affairs, MSD UK and Ireland. “Ezetimibe was found by NICE to be a cost-effective use of NHS resources whilst reducing future events in high risk patients, providing value in the primary and secondary care settings.”

Joel Levy

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