Bayer's heart failure drug Verquvo is recommended by the EU CHMP and approved by China to enter the review

Bayer recently announced that the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive review opinion recommending the approval of vericiguat, which is a soluble guanylate cyclase (sGC) stimulator Agent.

Vericiguat is an oral, once daily, first-in-class stimulator of soluble guanylate cyclase (sGC).

Vericiguat was jointly developed by Merck and Bayer, and the two parties reached a global cooperation in October 2014 to develop sGC regulators.

In January of this year, vericiguat was approved by the U.

It is worth mentioning that vericiguat is the first soluble guanylate cyclase (sGC) stimulator approved for the treatment of heart failure.

Patients with symptomatic chronic heart failure and reduced ejection fraction are at high risk of hospitalization after experiencing heart failure symptoms that require outpatient intravenous diuretic therapy or hospitalization.

The US FDA's approval of vericiguat and CHMP's recommendation to approve vericiguat are based on the results of the pivotal Phase 3 VICTORIA study.

It is worth mentioning that VICTORIA is the first contemporary outcome study specifically for symptomatic chronic heart failure patients (ejection fraction <45%) after experiencing worsening events.

For many patients with heart failure, worsening events may lead to worsening of the condition and poor prognosis.

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.

The results showed that the study reached the primary efficacy endpoint: when used in combination with available heart failure drugs, compared with placebo, the once-daily 10 mg dose of vericiguat significantly reduced the combined risk of heart failure hospitalization and cardiovascular death after worsening events by 10% (Relative risk reduction: HR=0.

This effect was consistent in most pre-specified subgroups, including patients who received or did not receive Entresto (sacubitril/valsartan).

In the baseline NT-proBNP analysis, patients were divided into 4 quartiles.

In the study, vericiguat was well tolerated and consistent with the safety profile observed in the previous vericiguat study.

Original source: Positive CHMP opinion for Bayer's new symptomatic chronic heart failure treatment vericiguat