Novartis’ heart failure drug misses expanded use trial target

Novartis has announced that its heart failure drug Entresto has failed in a trial that the company hoped would extend its use to a new group of patients with preserved ejection fraction.

Entresto tablets have already been approved for heart failure since 2015, but Novartis hoped to extend this use to heart failure with preserved ejection fraction (HFpEF), also known as diastolic heart failure, with further trial data.

But the phase 3 PARAGON-HF trial narrowly missed statistical significance for its composite primary endpoint of reducing cardiovascular death and total heart failure hospitalisations compared with valsartan alone.

Safety and tolerability on the trial involving 4,822 patients were consistent with previously reported data from Entresto, Novartis said.

Novartis gave no further details about the results, saying they will be announced at the ESC Congress in Paris in September.

There are no currently approved treatments for HFpEF and Novartis said that despite the disappointment regulators may still approve the drug.

Novartis’ chief medical officer John Tsai said: “The totality of evidence from the trial suggests that treatment with sacubitril/valsartan may result in clinically important benefits in HFpEF.

“We will be discussing potential next steps with clinical experts and regulators while we prepare to present the full results at the ESC Congress 2019 in September.”

In 2016 Novartis launched a big trials programme for Entresto to boost initially disappointing sales.

Late last year the company announced the PIONEER-HF trial showed Entresto is superior to the generic drug enalapril in heart failure with reduced ejection fraction.

The investment in Entresto seems to be finally paying off: sales grew 81% in Q2 compared with the same period last year to $421 million.

There will be further data on cardiac remodelling in reduced ejection fraction heart failure at ESC along with detailed results from PARAGON-HF.

Novartis also has other studies ongoing assessing Entresto against different endpoints.

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