Novartis plans to seek approval from the global health authorities for a twice-a-day heart failure pill. The results of their study showed that the pill was able to prolong the patients' lives without being hospitalized.
LCZ696 is a combination drug of two antihypertensives, valsartan and AHU-377. It is being developed as a new treatment for chronic heart failure which affects about 5.1 million people in the United States and costs the government about $32 billion each year.
On Monday, the Swiss pharmaceutical company announced that the Data Monitoring Committee (DMC), a panel that monitors the patients' safety and treatment efficacy, has agreed to end the clinical trial that began in 2009. They voted that that the company has already proven the efficacy of the pill by presenting a satisfactory report of safety profile.
"Novartis recognizes the huge global need for treatments that extend and improve the lives of people with heart failure and we believe LCZ696's unique mechanism of action could be transformative," said Tim Wright, Global Head of Development, Novartis Pharmaceuticals, in a news release. "This result is a demonstration of our commitment to developing innovative medicines that have an impact on the most important outcomes like cardiovascular mortality."
The researchers recruited 8,436 patients diagnosed with chronic heart failure who have been using enalapril, a standard medication, as maintenance. To prove the efficacy of LCZ696, they needed to provide evidence that it can prevent patients from being hospitalized while on the pill.
"The results of PARADIGM-HF are truly impressive" said Dr. Milton Packer, Professor and Chair for the Department of Clinical Sciences at University of Texas Southwestern Medical Center, Texas, USA and one of the two Principal Investigators, said in a news release. "The finding that treatment with LCZ696 was superior to currently recommended doses of enalapril has profound implications for the care of patients with chronic heart failure. We now have compelling evidence that supports LCZ696 as a new cornerstone in the management of chronic heart failure."
The results of the clinical study will be presented on an upcoming medical conference.