The European Commission (EC) has approved MSD and Bayer’s Verquvo for the treatment of symptomatic chronic heart failure in patients with reduced ejection fraction.
Specifically, the EC has cleared Verquvo (vericiguat) to treat patients who are stabilised after a recent decompensation event requiring intravenous therapy.
In the Phase III VICTORIA study, Verquvo met the primary efficacy objective based on a time-to-event analysis.
Over the duration of this study, investigators observed a 4.2% reduction in annualised absolute risk of cardiovascular death or heart failure hospitalisations compared to placebo.
“This announcement reflects another important regulatory milestone in the development of this medicine,” said Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories.
“The approval of Verquvo in the EU will provide doctors, health care professionals and patients with an important treatment option to complement currently available heart failure therapies,” he added.
MSD – known as Merck in the US and Canada – is jointly developing Verquvo with Bayer. While MSD hold the commercial rights to the heart failure med in the US, Bayer has the exclusive commercial rights in the rest of the world.
Earlier this year, the US Food and Drug Administration approved Verquvo to reduce the risk of cardiovascular death and heart failure hospitalisation, following a hospitalisation for heart failure or need for outpatients intravenous (IV) diuretics in adults with symptomatic chronic heart failure and ejection fraction less than 45%.