As the bestselling drug in the heart failure space, Novartis’ Entresto suffered a stinging setback last year in a novel indication—but there were some signs of hope.
Now, a new Entresto study is again showing promise in that patient population, but it’s not a resounding win.
Entresto had split success in improving symptom severity and heart functionality in heart failure patients with a preserved ejection fraction (HFpEF), according to late-breaking science presented Sunday at the European Society of Cardiology virtual annual meeting.
Novartis’ drug improved serum levels of biomarker NT-proBNP, an indicator of a patient’s heart failure severity, at the 24-week mark in study that also saw patients taking valsartan, an ACE inhibitor or placebo, the drugmaker said.
Entresto did miss one of the studies co-primary endpoints. It couldn’t significantly top other drugs in the phase 3 Parallax study at improving patients’ six-minute walking distance.
On a secondary endpoint, improving quality of life after 24 weeks, Novartis’ drug didn’t top its competitors, either.
Overall, it’s mixed win for Novartis as it looks to take its blockbuster medicine into an HFpEF population that has no approved therapies. But meanwhile, upstarts from the SGLT2 diabetes class are also gunning for those patients.
Back in June 2019, Novartis unveiled results from a phase 3 trial showing Entresto had posted a statistically insignificant 13% reduction in heart failure hospitalizations or death in HFpEF patients, seemingly shutting down the drug’s $5 billion peak sales goal.
Later in the year, though, Novartis pointed to subgroup analyses from that trial as a possible avenue for future studies and a more limited approval—data that seem to have resonated with cardiologists, according to SVB Leerink analysts.
In November, the Swiss drugmaker said heart failure patients with an ejection fraction below 57% showed a stronger clinical response on Entresto than patients with ejection fractions above that threshold.
Meanwhile, Entresto’s standing among cardiologists as the leading heart failure drug in the space could spell good things for its sales future.
In a July physician survey, SVB Leerink analysts found doctors had an overall positive view of Entresto’s clinical efficacy in heart failure patients with a reduced ejection fraction (HFrEF) and a consensus opinion that the drug’s uptake would rapidly build in the coming years as physicians grow more comfortable prescribing it to patients.
Meanwhile, those same cardiologists also talked up AstraZeneca’s Farxiga, an SGLT2 med that scored a first-of-its-kind FDA approval in May to treat HFrEF patients with or without Type 2 diabetes. Eli Lilly and Boehringer Ingelheim are pursuing a matching approval for their SGLT2 drug, Jardiance.
By: Kyle Blankenship
Source: Fierce Pharma
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