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Positive CHMP opinion for symptomatic chronic heart failure treatment vericiguat.- Bayer.

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Published:25th May 2021
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended vericiguat, a soluble guanylate cyclase (sGC) stimulator, for marketing authorization in the European Union. Once approved, the use of vericiguat (2.5 mg, 5 mg, and 10 mg) will be authorized for the treatment of symptomatic chronic heart failure in adult patients with reduced ejection fraction who are stabilised after a recent decompensation event requiring intravenous (IV) therapy.

“Even when taking guideline-based therapy, many heart failure patients still experience progressive worsening of symptoms – meaning hospitalization or initiation of intravenous diuretics is needed. This is one of the biggest challenges still to be addressed in the management of chronic heart failure, as sadly, one in five do not survive for longer than two years after a worsening heart failure event,” said Dr. Burkert Pieske, professor of internal medicine and cardiology at Charité and principal investigator of the Phase III VICTORIA trial. “Once approved, vericiguat will be the first treatment option to have been studied specifically in patients after a recent decompensation in order to help break the cycle of worsening events, reduce the risk of re-hospitalization and hopefully make a meaningful difference to the lives of both patients and their families.” The positive CHMP opinion is based on the results of the pivotal Phase III VICTORIA trial, published in The New England Journal of Medicine (NEJM) in March 2020. The data showed that vericiguat significantly reduced the combined risk of cardiovascular death or heart failure hospitalizations compared to background therapy alone, following a worsening heart failure event. Vericiguat has been approved by the FDA under the brand name Verquvo and the final decision from the European Commission is expected in the coming months.

Condition: Heart Failure
Type: drug

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