The application for the listing of a new Bayer/Mercado heart failure drug has been reviewed by the FDA on a priority review.

Reduced blood-shot fractions (HFrEF) heart failure, formerly known as constrictary heart failure, is characterized by impaired heart damage in its ability to shoot fully during its contractionIn the United States, 6.5 million people suffer from heart failure, of which about 40-50% have HFrEFEach year, about 30 percent of patients with chronic heart failure experience a worsening of the disease, about half of those with chronic HFrEF deterioration re-hospitalized within 30 days of the deterioration, and it is estimated that one-fifth of patients with chronic HFrEF deterioration will die within two yearsVericiguat is an oral, once-daily, direct water-soluble birdnucleic cyclate (sGC) agonisant developed jointly by Mercado and BayerSGC is important for both vascular and heart function, however, sGC cannot be fully activated in patients with heart failure, leading to abnormal heart muscle and vascular functionVericiguat actively restores the function of the key pathway (NO-sGC-cGMP) that current therapies cannot solveIn May 2014, Bayer and Mercado reached a research and development agreement to jointly develop and promote vericiguatVericiguat Molecular Structure (Photo: PubChem) This application for a new drug submitted to the FDA is based on the results of a Phase 3 clinical trial called VICTORIA, which is the first contemporary outcome study for people with an increased risk of chronic heart failure, a high risk of cardiovascular disease death and repeated heart failure hospitalizationTHE DATA FROM VICTORIA WAS PRESENTED AT THE AMERICAN COLLEGE OF CARDIOLOGY'S 69TH ANNUAL SCIENTIFIC CONFERENCE AND THE WORLD CONGRESS OF CARDIOLOGY (ACC.20/WCC) AND PUBLISHED IN THE NEW ENGLAND JOURNAL OF MEDICINEThe results showed that vericiguat reduced the risk of combined endpoint severity of heart failure hospitalization or cardiovascular death compared to placebosThe median follow-up for 10.8 months showed that the vericiguat treatment group had a lower risk of heart failure hospitalization and cardiovascular-related death (35.5% vs 38.5%, HR 0.90) compared to the placebo groupDr Joerg Moeller, head of Research and Development at Bayer, said: "Heart failure is the number one cause of hospitalization for patients over 65 years of age and affects more than 60 million people worldwideAlthough patients with heart failure receive existing treatment, many continue to experience worsening conditions that lead to repeated hospitalizationsThe submission of The Application for a Listing by Veliguat is expected to keep heart failure patients away from hospital spending longer and staying healthy for longer"We look forward to working with the FDA to expedite the review of new drug applications for the vericiguat," said DrRoy Baynes, Chief Medical Officer, Senior Vice President and Global Clinical Development Director, Mersadon LabsReferences: FDA Grants Priority Review to Merck's New Drug Application for VericiguatRetrieved 2020-07-16, from