Access to medicines
Sacubitril/valsartan combination fast-tracked to heart failure patients
A new drug to reduce the risk of cardiovascular mortality and morbidity in adults with symptomatic heart failure and reduced ejection fraction is being fast-tracked to patients under the UK’s Early Access to Medicines Scheme (EAMS).
Sacubitril/valsartan has been given a positive scientific opinion by the UK’s medicines safety watchdog, which means it is now available to patients under the scheme.
The EAMS is designed to make unlicensed innovative drugs available to patients who have debilitating or life-threatening conditions without the need to wait for the lengthy licensing process to be completed.
The Medicines and Healthcare products Regulatory Agency (MHRA) positive scientific opinion was based on the results of a clinical trial of sacubitril/valsartan compared with enalapril — an established angiotensin-converting enzyme inhibitor used for the treatment of patients with heart failure.
Half the 8,442 trial participants — all of whom had heart failure and reduced ejection fraction — were given enalapril and half sacubitril/valsartan for more than two years.
Some 21.8% of patients on the new fixed combination drug either died from cardiovascular causes or were admitted to hospital with heart failure during the study compared with 26.5% receiving enalapril. The overall death rate of patients given the new product was 17% compared with 19.8% receiving enalapril.
The MHRA says there is a significant need for more effective therapies to prevent death in these patients and help them lead a more normal life when discharged from hospital. The benefits of sacubitril/valsartan outweighed its risks, its scientific opinion concludes.
Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2015.20069267
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