Obtain information on the background and timeline of the Entresto drug. The information will be used to understand more about the history of the drug.
ENTRESTO DRUG OVERVIEW
ENTRESTO APPROVAL HISTORY
- On August 27, 2012, the "new Novartis Phase II data" indicated that LCZ696 may have a positive clinical impact on patients with severe cases of heart disease.
- On August 30, 2014, it was proven in a landmark PARADIGM-HF trial that the drug slashes cardiovascular mortality instances by 20% as compared to the ACE-inhibitor.
- On November 17. 2014, nine new studies revealed that the drug has the power to alter the course of heart disease in patients.
- By February 13, 2015, the drug got an FDA priority review.
- Entresto was first approved by the FDA last July 7. 2015.
- Its previous name was LCZ696 and it comes in tablets.
- The drug is manufactured by the Novartis Pharmaceuticals Corporation.
- The approval of the drug was "based on results from the 8,442-patient PARADIGM-HF study" which was ceased early when it was proven that Entresto greatly lowered the risk of cardiovascular mortality and hospital confinements that are linked to heart failure as compared to the ACE-inhibitor enalapril.
- Insights on the safety data revealed that Entresto had the same tolerability level as enalapril.
- However, in the recent "Paragon-HF phase 3 clinical trials," Entresto has "narrowly missed its primary endpoint in a trial of patients with preserved ejection fraction (HFpEF)."
- The trial missed to show the statistical importance of its main objective of lowering cardiovascular mortality and overall heart failure confinements.
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