Novartis’ PARAGON-HF Trial Evaluating Entresto in HFpEF Misses Primary Endpoint

July 25, 2019

Impact: High

Get insight from inThought Research experts on Novartis results from the phase 3 PARAGON-HF clinical trial evaluating Entresto versus valsartan in HFpEF.

• Novartis announced topline results from the phase 3 PARAGON-HF study evaluating Entresto versus valsartan in HFpEF.
• The primary endpoint of reducing cardiovascular death and total heart failure hospitalizations did not reach reach statistical significance.
• The data will be presented at the ESC Congress in September.
• Scott Solomon M.D., the trial co-chair, noted that the full trial results may results in clinically meaningful benefits in patients with HFpEF and that the company will discuss next steps with clinical experts and regulators. 

inThought Analysis

This is obviously a huge blow to Novartis, as they were hoping that Entresto would be as effective for patients with HFpEF as it is for those with HFrEF. Now with the PARAGON-HF topline data, it is highly unlikely that regulators would accept an application for a label update. 

This leaves the door open for various competitors to obtain first approval for HFpEF, with Lilly/Boehringer’s Jardiance, which received Fast Track designation last month, likely the furthest ahead at this point. Depending on the full results of the PARAGON-HF trial, there is the possibility that physicians will use Entresto off-label for HFpEF until something is officially approved. 

Novartis is running a smaller trial for Entresto in HFpEF (PARALLAX) that has an expected primary completion of Dec 2019.

Source: Novartis Press Release