Entresto Drug: Challenges
Insights around the challenges of regulatory approvals for the Entresto drug include the presence of a lengthy regulatory approval process of drugs in the United States and the strict considerations put on clinical trial results before approval is granted. These two challenges were evident in the research analysis conducted on Entresto's use in the two major types of chronic heart failure disease i.e. heart failure with reduced ejection fraction (HFrEF) and heart failure with preserved ejection fraction (HFpEF). A detailed look at these insights follows below.
LENGTHY REGULATORY APPROVAL PROCESS
- One insight on the regulatory approval challenges for the Entresto drug is evident in the presence of a very lengthy regulatory approval process that was put in place by the Food and Drug Administration's Center for Drug Evaluation and Research (CDER).
- Before CDER starts to evaluate a drug, the pharmaceutical company behind the drug must conduct extensive testing of the drug and document all results.
- After submitting these results, CDER "assigns a team of doctors, chemists, pharmacologists, and other scientists to review the evidence" and typically, the process from the start to the successful end of acquiring FDA approval may take as much as 10 years.
- For instance, in the approval of Entresto for the treatment of heart failure with reduced ejection fraction (HFrEF), it took close to 3 years for the drug to move from clinical trials and reporting, to full fledged FDA approval for the treatment of HFrEF.
- The FDA approval of the Entresto drug resulted from the success of the PARADIGM-HF study, which featured 8,442 patients and proved that the drug was effective in "significantly reducing the risk of cardiovascular death and hospitalizations related to heart failure."
- Novartis Pharmaceuticals Corporation, which is the company behind Entresto is still in the lengthy process of seeking FDA approval for the use of the drug in the treatment of a second type of chronic heart disease i.e. heart failure with preserved ejection fraction (HFpEF).
STRICT CONSIDERATION OF CLINICAL TRIAL RESULTS BEFORE APPROVAL
- Another challenge that the Entresto drug is facing in acquiring regulatory approval for the treatment of the other type of heart failure i.e. heart failure with preserved ejection fraction (HFpEF) is the strict considerations put on clinical trial results before approval is given by the FDA.
- This is evident in the recently concluded clinical trial where Norvatis "narrowly missed its primary endpoint in a trial of patients that are living with HFpEF."
- The PARAGON-HF trial was conducted as part of the FDA's regulatory process before Entresto was given approval for the treatment of HFpEF.
- Because the trial's results failed to prove the statistical significance of Entresto in the reduction of cardiovascular mortality and heart failure hospitalization in patients suffering from HFpEF, the drug failed to proceed towards FDA approval for this particular treatment scenario.
- Although these controls are put in place for the safety of patients, they did pose an approval challenge to the Entresto drug in the treatment of HFpEF.