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Novartis announces large HF clinical trial program
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Novartis has announced the launch of FortiHFy, a large global clinical trial program comprising more than 40 active or planned studies of combination sacubitril and valsartan for the treatment of HF.
The goal of the Fortify Heart Failure clinical evidence and patient quality of life (FortiHFy) program is to generate additional data on symptom reduction, efficacy, safety, quality of life and real-world evidence with sacubitril/valsartan (Entresto, Novartis), according to a press release.
The program will enroll patients from more than 50 countries worldwide, including the United States, to participate over 5 years. Major trials in FortiHFy include PARAGON-HF, PARADISE-MI, TRANSITION-HF and PIONEER-HF, according to the release.
In July 2015, the FDA approved the first-in-class angiotensin receptor-neprilysin inhibitor for the reduction of CV death and HF-related hospitalization for use in patients with HF with reduced ejection fraction (HFrEF). Sacubitril/valsartan is administered in tablet form twice a day, in place of an ACE inhibitor or angiotensin receptor blocker. Approval followed results of the PARADIGM-HF trial, which was stopped early due to significant reductions in the risk for CV death or HF-related hospitalization among patients treated with sacubitril/valsartan compared with placebo.
The outcomes of the trials in FortiHFy will provide additional information on patient populations that may benefit from sacubitril/valsartan, and could potentially support future regulatory applications for additional indications, according to the release.