Merck and Bayer have announced that the companies have received the US FDA's approval for Verquvo (vericiguat).
The drug is approved for treating patients at risk of cardiovascular death and heart failure (HF) hospitalization following hospitalization for HF or adult patients suffering from chronic heart failure and require IV diuretics.
Verquvo (vericiguat) is a soluble guanylate cyclase (sGC) stimulator and is the first approved treatment option for the specific target population.
The approval was based on the Phase 3 VICTORIA trial. The primary endpoint is the duration for the first occurrence of the composite endpoint of cardiovascular death or heart failure hospitalization. The drug was compared with the placebo. Eleven months is the median duration time to determine the primary endpoint. The patients were administered either placebo or 10 mg Verquvo. After one year, 90% of patients in both arms were treated with Verquvo 10 mg. Based on the time-to-event analysis, Verquvo has met the primary endpoint. The annual absolute risk was reduced by 4.2% in the Verquvo arm compared to the placebo.
The drug is contraindicated to pregnant women as it might harm the fetus.
Merck and Bayer jointly developed Verquvo. Merck attains the commercial rights in the US, and Bayer have the commercial rights for the rest of the world.