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New heart failure medicine recommended by CHMP for EU approval

News - Sep. 25, 2015

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicine’s Agency (EMA) as adopted a positive opinion for sacubitril/valsartan, marking an important milestone towards becoming available in the EU. Pending final approval by the European Commission (EC) sacubitril/valsartan, previously known as LCZ696, will be available for the treatment of adult patients with symptomatic chronic heart failure and reduced ejection fraction (HFrEF).

The agent is a combination of valsartan (an ARB) and sacubitril. Sacubitril is the first in a new class of medicines called neprilysin inhibitors. Sacubitril/valsartan works in two ways – valsartan blocks the angiotensin II type-1 receptor, suppressing the harmful effects of angiotensin II on the cardiovascular system while sacubitril blocks the enzyme neprilysin to enhance the protective neurohormonal systems of the heart. Because of its mechanism of action sacubitril/valsartan should not be given together with another ARB or with an ACE inhibitor.

The CHMP’s decision, which follows previous US and Swiss approvals, is based on results from the 8442-patient randomised PARADIGM-HF study in patients with HFrEF. Patients also received other heart failure medicines. Patients were included in the trial if they were able to tolerate treatment with sacubitril/valsartan, i.e. they did not need to stop treatment with sacubitril/valsartan due to side effects during a run-in period before the start of the trial. The patients were followed for a median of 27 months.  The trial was stopped early when it was shown sacubitril/valsartan significantly reduced the risk of cardiovascular death versus ACE-inhibitor enalapril (13.3% vs. 16.5%). At the end of the study patients who were given sacubitril/valsartan were more likely to be alive and less likely to have been hospitalized for heart failure than those given enalapril.

Analysis of safety data showed that sacubitril/valsartan had a similar tolerability profile to enalapril. The most common side effects reported with sacubitril/valsartan were hypotension, hyperkalaemia and kidney impairment. Therefore, CHMP recommended that treatment should not be started in patients with low blood pressure or high potassium levels. A follow-up plan to monitor the safety of sacubitril/valsartan, including the risk of angioedema, was agreed by the CHMP.

“The striking results in the PARADIGM-HF trial led me to believe that once approved LCZ696 could quickly replace what has been the bedrock treatment for more than 20 years, ACE-inhibitors” said Professor John McMurray of the University of Glasgow and one of two Principal Investigators. “Thousands of lives could be extended and hospital admissions prevented with LCZ696’s unique ability to boost natriuretic peptides, while simultaneously inhibiting the RAAS system.”

Press release Novartis and EMA CHMP September 25

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