drugs

Neparvis - Sacubitril / Valsartan

What is Neparvis - Sacubitril / Valsartan and what is it used for?

Neparvis is a heart medicine that contains the active substances sacubitril and valsartan. It is used in adults with chronic heart failure who experience symptoms of the disease. Heart failure is characterized by the inability of the heart to pump the required amount of blood throughout the body.

This medicine is the same as Entresto, already authorized in the European Union (EU). The manufacturer of Entresto has accepted that its scientific data can be used for Neparvis ("informed consent").

How is Neparvis - Sacubitril / Valsartan used?

Neparvis is available as tablets (24 mg sacubitril / 26 mg valsartan, 49 mg sacubitril / 51 mg valsartan and 97 mg sacubitril / 103 mg valsartan). The medicine can only be obtained with a prescription.

Neparvis tablets should be taken twice a day. The recommended starting dose of Neparvis is one 49 mg / 51 mg tablet twice a day. The dose should then be doubled after 2-4 weeks up to 97 mg / 103 mg twice a day. For some patients the doctor may decide to use lower doses. For more information, see the summary of product characteristics (included with EPAR).

How does Neparvis - Sacubitril / Valsartan work?

The two active ingredients of Neparvis, sacubitril and valsartan, act in different ways. Sacubitril blocks the breakdown of natriuretic peptides produced in the body. Natriuretic peptides determine the passage of sodium and water into the urine, thus reducing the strain on the heart. Natriuretic peptides also reduce blood pressure and protect the heart from the development of fibrosis (scar tissue) secondary to heart failure.

Valsartan is an "angiotensin II receptor antagonist"; this means that it inhibits the action of a hormone known as angiotensin II. The effects of angiotensin II can be harmful in patients with heart failure. By blocking the receptors normally associated with angiotensin II, valsartan blocks the harmful effects of the hormone on the heart, as well as reducing blood pressure, allowing the blood vessels to dilate.

What benefit has Neparvis - Sacubitril / Valsartan shown during the studies?

Neparvis has been shown to be effective in treating heart failure in a main study. In the study, Neparvis was compared to enalapril, another medicine used for heart failure. The patients who participated in the study had chronic heart failure with manifest symptoms of the disease and reduced ejection fraction (the portion of blood expelled from the heart). In the group treated with Neparvis, 21.8% (914 out of 4.187) of patients died of cardiac and circulatory problems or were hospitalized for heart failure compared to 26.5% (1, 117 of 4, 212) of patients treated with enalapril. In general, patients were monitored for approximately 27 months. During this period they took the medicine on average for about 24 months. The study was stopped early because convincing evidence emerged about the greater efficacy of Neparvis compared to enalapril

What is the risk associated with Neparvis - Sacubitril / Valsartan?

The most common side effects of Neparvis (which may affect more than 1 in 10 people) are high blood levels of potassium, low blood pressure and reduced kidney function. A potentially serious but uncommon side effect (affects less than 1 in 100 people) is angioedema (rapid swelling of the deeper skin tissues and those around the throat resulting in difficulty breathing). For the full list of all side effects reported with Neparvis, see the package leaflet.

Neparvis should not be taken with medicines known as ACE inhibitors (used to treat heart failure and hypertension). It must not be taken by patients who have suffered from angioedema, by patients with severe liver disease or by pregnant women. For the full list of limitations, see the package leaflet.

Why has Neparvis - Sacubitril / Valsartan been approved?

The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Neparvis's benefits are greater than its risks and recommended that it be approved for use in the EU. The main study revealed that Neparvis reduced the number of deaths due to heart and circulatory problems, as well as hospitalization due to heart failure.

The serious side effects attributed to Neparvis in the main study were similar to those reported for enalapril, a medicine already authorized for use in cases of heart failure. The use of valsartan, one of the active ingredients of the medicine, is well established for the treatment of hypertension and heart failure; its side effects are well known.

What measures are being taken to ensure the safe and effective use of Neparvis - Sacubitril / Valsartan?

A risk management plan has been developed to ensure that Neparvis is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Neparvis, including the appropriate precautions to be followed by healthcare professionals and patients.

More information on Neparvis - Sacubitril / Valsartan

For the full EPAR for Neparvis, consult the Agency's website: ema.europa.eu/Find medicine / Human medicines / European public assessment reports. For more information about treatment with Neparvis, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.