Another important milestone for Verquvo with EC approval

The European Commission has granted marketing authorization in the European Union (EU) for vericiguat under the brand name Verquvo.

Originated by Germany’s Bayer (BAYN: DE), the drug has been out-licensed to pharma giant Merck & Co (NYSE: MRK) for the US market, and the companies will split the profits under the terms of a co-development agreement.

Verquvo (2.5mg, 5mg, and 10mg), 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,” he noted.