July 21, 2021: “The European Commission has granted marketing authorization in the EU for vericiguat under the brand name Verquvo™.
Verquvo (2.5 mg, 5 mg, and 10 mg), a soluble guanylate cyclase (sGC) stimulator, is indicated for symptomatic chronic heart failure in adult patients with reduced ejection fraction who are stabilized after a recent decompensation event requiring intravenous (IV) therapy.
It works differently to existing heart failure treatments, providing a specific approach to managing chronic heart failure patients following a decompensation event, also known as a worsening event.
“With this latest approval, we have the potential to bring new hope to patients living with heart failure, by breaking the cycle of decompensation events, also known as worsening events, and reducing the risk of re-hospitalization,” said Dr. Burkert Pieske, professor of internal medicine and cardiology at Charité and principal investigator of the Phase III VICTORIA trial.
“Re-hospitalization has a significant impact on both patients and their families, and even when taking guideline-based therapy, many will still experience progressive worsening of symptoms.
Therefore, access to a new treatment that has been developed with these patients specifically in mind, is extremely welcome news.”
Current therapies block the harmful effects of the natural neurohormonal systems that are activated by the myocardial and vascular dysfunction present in heart failure. Vericiguat works in conjunction with existing approaches through a different mode of action.
It specifically restores the deficient NO-sGC-cGMP pathway, which plays a critical role in the progression of heart failure and aggravating its symptoms.
“The approval of Verquvo in the EU represents a significant breakthrough for those living with this condition,” said Dr. Michael Devoy, Chief Medical Officer and Head of Medical Affairs and Pharmacovigilance at Bayer’s Pharmaceuticals Division.
“As the leading cause of hospitalization in Europe, it is vital we continue to make such advances to improve patients’ quality of life. Currently half of patients with heart failure are readmitted within 30 days of hospitalization or initiation of intravenous diuretics.
We believe availability of Verquvo provides clinicians with a much-needed new option to help alleviate the huge burden of chronic heart failure.”
Verquvo (vericiguat) has been approved by the U.S. Food and Drug Administration (FDA) and the Ministry of Health, Labour, and Welfare (MHLW) in Japan.
Vericiguat has also been submitted for marketing authorization in China as well as multiple other countries worldwide.
Vericiguat is being jointly developed with MSD (a tradename of Merck & Co., Inc., Kenilworth, NJ, USA).
About Verquvo™ (vericiguat)
Verquvo 2.5 mg, 5 mg, and 10 mg is an oral once daily stimulator of soluble guanylate cyclase (sGC), an important enzyme in the nitric oxide (NO) signaling pathway.
When NO binds to sGC, the enzyme catalyzes the synthesis of intracellular cyclic guanosine monophosphate (cGMP), a second messenger that plays a role in the regulation of vascular tone, cardiac contractility, and cardiac remodeling.
Heart failure is associated with impaired synthesis of NO and decreased activity of sGC, which may contribute to myocardial and vascular dysfunction.
By directly stimulating sGC, independently of and synergistically with NO, vericiguat augments levels of intracellular cGMP, leading to smooth muscle relaxation and vasodilation.”