Regulatory applications for vericiguat to treat symptomatic chronic heart failure are filed in the EU and Japan.- Bayer HealthCare + Merck Inc.

Bayer announced the submission of two regulatory applications seeking the approval of vericiguat in the EU and Japan. Vericiguat is an investigational oral, once-daily, first-in-class soluble guanylate cyclase (sGC)-stimulator being developed to treat patients with symptomatic chronic heart failure with an ejection fraction less than 45% who have had a previous worsening heart failure event (defined as heart failure hospitalization or receiving an intravenous diuretic for heart failure without hospitalization) in combination with available heart failure therapies. Vericiguat is being jointly developed with Merck inc.,

“Despite significant advances in treatment, many patients with heart failure and reduced ejection fraction still experience worsening events – even when taking guideline-based therapy. This reality puts them at an increased risk for frequent heart failure hospitalizations or the need for urgent treatment,” said Paul W. Armstrong, M.D., cardiologist and Distinguished University Professor of Medicine at the Canadian VIGOUR Centre, University of Alberta. “Vericiguat has a specific mechanism of action that distinguishes it from other current heart failure treatments. The absolute risk reduction in heart failure hospitalization and cardiovascular mortality of 4.2 per 100 patient years observed in the VICTORIA data recently presented at ACC.20/WCC Virtual and published in the New England Journal of Medicine is a gratifying result for these heart failure patients. If approved, vericiguat will give clinicians an important and welcome new option to augment existing treatment.”

The marketing authorization application (MAA) submitted to the European Medicines Agency (EMA) and the new drug application (NDA) submitted to the Ministry of Health, Labor and Welfare (MHLW) in Japan were based on positive Phase III data from the VICTORIA study.