Bayer/MSD heart failure drug gains EC approval

pharmafile | July 22, 2021 | News story | |   

The European Commission (EC) has approved MSD and Bayer’s Verquvo (vericiguat) for the treatment of symptomatic chronic heart failure in patients with reduced ejection fraction.

The drug has been specifically cleared for the treatment of patients who are stabilised after a recent decompensation event requiring intravenous therapy.

The approval follows positive data from the Phase III VICTORIA study, wherein Verquvo met the primary efficacy objective based on a time-to-event analysis.

Over the duration of this study, investigators observed a 4.2% reduction in annualised absolute risk of cardiovascular death or heart failure hospitalisations compared to placebo.

Roy Baynes, Senior Vice President and Head of Global Clinical Development, Chief Medical Officer, Merck Research Laboratories, said: “This announcement reflects another important regulatory milestone in the development of this medicine. The approval of Verquvo in the EU will provide doctors, health care professionals and patients with an important treatment option to complement currently available heart failure therapies.”

Earlier this year, the US Food and Drug Administration approved Verquvo to reduce the risk of cardiovascular death and heart failure hospitalisation, following a hospitalisation for heart failure or need for outpatients intravenous (IV) diuretics in adults with symptomatic chronic heart failure and ejection fraction less than 45%.

MSD – known as Merck in the US and Canada – is jointly developing Verquvo with Bayer. While MSD hold the commercial rights to the drug in the US, Bayer has the exclusive commercial rights in the rest of the world.

Verquvo is a stimulator of soluble guanylate cyclase (sGC), an important enzyme in the nitric oxide (NO) signalling pathway. When NO binds to sGC, the enzyme catalyses 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 remodelling.

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.

Kat Jenkins

Related Content

No items found

Latest content