Entresto Overview

Goals

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.

Early Findings

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.

Proposed next steps:

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Our initial research provided some information on the Entresto drug. Given that there are available resources on this topic, we propose continuing the research to deliver the specified data points in several research blocks. (1) Provide 2-3 insights around the regulatory approvals and challenges of the Entresto drug. (2) Provide 2-3 insights about the drug's distribution in new regions. (3) Provide 2-3 insights on any instances of drug approvals to address new needs. (4) Provide 2-3 competitors of Entresto that are planning to enter the market. For each competitor, we will provide a 1-2 sentence overview of the drug and the website of the competitor. (5) Provide 2-3 insights about the licensing agreements of the drug. (6) Provide 2-3 insights on any other additional information about the drug that is not included in the above.
We also recommend continuing the research to deliver a full competitive analysis of the 2-3 competitors of Entresto that were identified above. For each competitor, we will include the list of offerings, competitive advantage, and target market.
For a more affordable option, we will provide 5-7 general insights concerning the Entresto drug.