Bayer's first sGC stimulant filed for listing in China

Bayer recently announced that it has filed a licensing application for vericiguat, an oral, daily, first-in-class soluble bird nucleotide cyclase (sGC) stimulant in China. Currently being developed: a jointly available heart failure drug for the treatment of patients who have experienced worsening heart failure events (defined as: hospitalization for heart failure or treatment of heart failure with intravenous diuretics without hospitalization), shot blood fraction <45%, and symptomatic chronic heart failure.Vericiguat is being developed jointly by Bayer and Merca East. The two sides reached a global partnership in October 2014 to develop sGC regulators. Although sGC is important for both blood vessel and heart function, in patients with heart failure, the availability of nitric oxide (NO) is impaired and sGC stimulation is insufficient, leading to dysfunction of the heart muscle and blood vessels. In the treatment of heart failure, vericiguat is a pioneering sGC stimulant in late clinical development.Vericiguat's new drug application (NDA) has been submitted to the Drug Review Center (CDE) of the State Drug Administration (NMPA). To date, Vericiguat has filed for listing in the United States, the European Union, Japan and other countries. In July, the FDA conducted a priority review of the NDA submitted by Mercedon.The application is based on the positive results of the Phase III VICTORIA study. The findings were presented at the American College of Cardiology's Annual Scientific Meeting/World Congress of Cardiology (ACC.20/WCC Virtual) virtual meeting in March and published in the New England Journal of Medicine (NEJM), the world's top medical journal. The article is entitled: Vericiguat in Patients with Heart Failure and Reduced Ejection Fraction.It's worth noting that VICTORIA is the first contemporary outcome study specifically for patients with symptomatic chronic heart failure (shooting score <45%) who experience worsening events. The data showed that a daily dose of 10 mg of vericiguat significantly reduced the relative risk of hospitalization for heart failure and cardiovascular death after worsening events by 10% (p-0.019) and an absolute risk reduction of 4.2/100 patient years compared to available heart failure drugs.For many heart failure patients, worsening events can lead to worsening conditions with poor prognosis, with about 50% of patients unfortunately dying within five years of diagnosis. The VICTORIA study was the first positive contemporary outcome test for a group of patients with previously worsening heart failure events, reduced blood test scores, and symptomatic chronic heart failure. The findings of the study open up new possibilities for the treatment of chronic heart failure.Dr Joerg Moeller, executive committee member and head of research and development at Bayer Pharmaceuticals, said: "About 50 per cent of patients with worsening heart failure events are admitted to hospital within 30 days, double the risk of death with each hospitalization. Early identification and improved treatments can reduce these risks. With about 13.7 million heart failure patients in China, new treatments are urgently needed to help ease the burden of the disease. VICTORIA is a randomized, placebo-controlled, parallel group, multi-center, double-blind Phase III study conducted in more than 600 clinical centers in 42 countries around the world, with a total of 5,050 patients who experienced worsening heart failure events, shot blood fractions below 45%, and had symptomatic chronic heart failure. In the study, patients were randomly assigned to receive a daily vericiguat (titration to 10 mg, n to 2526) or a placebo (n to 2524) while receiving available heart failure medications. The main endpoint is a compound of hospitalization for cardiovascular death or heart failure. Compared to recent heart failure prognostic trials, the annual placebo event rate at the primary endpoint was more than 2 times higher and the baseline level of the disease prognostic marker (NT-proBNP) was 2 times higher, making these patients at higher risk of hospitalization or death.The results showed that the study reached the primary therapeutic endpoint: a 10 mg dose per day compared to a placebo when combined with available heart failure drugs significantly reduced the compound risk of heart failure hospitalization and cardiovascular death after worsening events by 10% (relative risk reduction: HR 0.90, 95% CI: 0.82-0.98, p-0.019);This effect is consistent in most pre-specified subgroups, including patients who accept or do not accept Entresto (sacubitril/valsartan, shakab querzatan). Baseline NT-proBNP levels and age were associated with therapeutic effects. In the study, data suggest that most patients with NT-proBNP in the lower quarter-digit range and those under 75 may have benefited more.In the baseline NT-proBNP analysis, the patient was divided into four four-digits. The overall therapeutic benefits were driven by patients with a lower 3-digit scale, where the relative risk of major compound endpoints was reduced by between 18 and 27 percent.In the study, vericiguat's tolerance was good, consistent with the safety profile observed in the previous vericiguat study, and the overall occurrence of severe adverse events in the vericiguat and placebo groups was similar (32.8% vs 34.8 %) , symptomatic hypotension (9.1% vs 7.9%) and fainting (4.0% vs 3.5%) were more common in the vericiguat group than in the placebo group, but the difference was not statistically significant. (Bio Valley Bioon.com)original source: Bayer submits vericiguat for marketing authorization in China for the treatment of chronic heart failure