Merck’s experimental heart failure drug rolofylline failed to meet the goals in a clinical trial, failing to improve patients. Merck won’t seek approval this year for this heart failure drug rolofylline after preliminary results.
“Advances to help patients with acute heart failure, a disease that is the leading cause of hospitalization for patients over age 65 and that is associated with a high rate of mortality, have long been elusive,” said Dan Bloomfield, M.D., executive director, cardiovascular research, Merck Research Laboratories.
“These results are disappointing because we had been hopeful that blocking the adenosine A1 receptor with rolofylline would prove to be a useful new approach for these patients” said Dan Bloomfield.
Merck & Co., Inc. today said that preliminary results for the pivotal Phase III study of rolofylline (MK-7418), the Company’s investigational medicine for the treatment of acute heart failure, show that rolofylline did not meet the primary or secondary efficacy endpoints. While Merck will continue to analyze the data with outside experts, the Company will not file applications for regulatory approval this year. The results from this study will be presented at a medical meeting later this year.
“Merck remains committed to discovering and developing novel treatments for heart failure and for cardiovascular disease, which claim more than 17 million lives worldwide each year and remain the leading cause of death and a leading cause of disability,” Dr. Bloomfield said.
Source: Merck & Co., Inc., USA