20 January 2021 - Vericiguat (Verquvo) is the first soluble guanylate cyclase stimulator to be approved for the treatment of symptomatic chronic heart failure / Vericiguat works on a pathway not currently targeted by existing heart failure treatments.
Bayer announced today that the U.S. FDA has approved soluble guanylate cyclase stimulator vericiguat under the brand name Verquvo.
Vericiguat (Verquvo) 2.5 mg, 5 mg, and 10 mg is indicated to reduce the risk of cardiovascular death and heart failure hospitalisation following a hospitalisation for heart failure or need for outpatient intravenous diuretics in adults with symptomatic chronic heart failure and ejection fraction less than 45%.
The approval is based on the results of the pivotal Phase 3 VICTORIA trial, published in the New England Journal of Medicine in March 2020, and follows priority review designation granted by the FDA.