The approval reflects another important regulatory milestone in the development of the medicine which will provide doctors, health care professionals and patients with an important treatment option to complement currently available heart failure therapies.
Merck and Bayer jointly co-developed Verquvo with Merck holding the commercial rights to the heart failure drug in the US and Bayer having exclusive commercial rights globally.
The drug relayed successful data during its phase 3 Victoria study as it met the primary efficacy objectives based on a time-to-event analysis.
Victoria study was a randomized, placebo-controlled, parallel-group, multi-center, double-blind Phase III study investigating Verquvo versus placebo in combination with available heart failure therapies in patients with worsening chronic heart failure with reduced ejection fraction (HFrEF).
The study enrolled 5,050 patients with HFrEF who were randomized to receive either Verquvo once daily (titrated up to 10mg) or placebo in combination with available heart failure therapies.
About Heart Failure
Heart failure is a highly prevalent chronic condition, affecting more than 60 million people worldwide, characterized by the progressive decline in the heart’s ability to pump enough blood to meet the body’s needs for blood and oxygen.
Despite advances in therapy and prevention efforts, heart failure remains as malignant as some common cancers.
In the U.S. and Europe, 50-60% of hospitalized heart failure patients can be classified as HFrEF. Annually, approximately 30% of patients with symptomatic chronic heart failure will experience worsening of the disease, which is marked by progressive symptoms and/or a recent heart failure event.
More than half of patients with worsening chronic HFrEF are rehospitalized within 30 days of the worsening event, and 1 in 5 patients with worsening chronic HFrEF will die within 2 years.
The heart failure (HF) market is expected to grow from $3.7bn in 2018 to $22.1bn in 2028 across the eight major markets at an impressive compound annual growth rate (CAGR) of 19.5%, according to GlobalData.
Out of the findings, the phase III trial met its primary endpoint, establishing Jardiance a therapy to significantly reduce the risk of the composite of cardiovascular death or hospitalization for heart failure in adults, with or without diabetes, who live with HFpEF.
A supplemental New Drug Application (sNDA) for Jardiance to reduce the risk of cardiovascular death or hospitalization for heart failure in adults with HFrEF has been submitted to the U.S. Food and Drug Administration (FDA), with a decision expected later this year.