Novartis announced today an enormous clinical trial program with its promising but slow-starting heart failure drug valsartan/sacubitril (Entresto). The company said it would perform 40 clinical trials with the drug in the next 5 years.
The Fortifying Heart Failure clinical evidence and patient quality of life (FortiHFy) program will include investigators and patients from more than 50 countries. The program will almost certainly dwarf all previous clinical programs in heart failure.
“The FortiHFy program reinforces our long-term commitment to improving heart failure treatment for as many people as possible,” said Vas Narasimhan, the global head of drug development and the chief medical officer of Novartis, in a press release. “The outcomes of these trials will increase our understanding of heart failure, the patient population who may benefit from Entresto, and could potentially support applications to regulatory authorities.”
Despite a highly successful result in the pivotal PARADIGM-HF trial and rapid approval of the drug in most major markets, Entresto has struggled to gain acceptance in the marketplace. In a recent editorial, Milton Packer, MD, the co-principal investigator of PARADIGM-HF, criticized the slow uptake of the drugs. One contributing factor, he said, was the lengthy delay between the completion of clinical trials and the update of guidelines. Updated heart failure guidelines are expected to be announced this weekend in conjunction with the beginning of the large European Heart Failure meeting in Florence, Italy.
Novartis had previously announced the PARAGON-HF trial, which is studying Entresto in heart failure patients with with preserved ejection fraction and is expected to be completed in 2019. Other trials announced by Novartis include PARADISE-MI, in post-MI patients, and TRANSITION, examining in-hospital initiation of Entresto following hospitalization for acute decompensation.