Novartis’ Summer Blockbuster LCZ696 Gains A Name, Skips An Advisory Panel

, , ,

Entresto. That’s the brand name Novartis has chosen for LCZ696, its new heart failure drug that is expected to be a blockbuster. The name won’t be final until official confirmation, which comes with FDA approval. But Novartis will introduce the name for the first time this weekend in presentations at the European Society of Cardiology Heart Failure meeting in Seville, Spain.

FDA approval of Entresto is expected to occur by August at the latest. There are no apparent roadblocks to approval since Novartis has stated that it doesn’t expect an FDA advisory panel. Approval might well come earlier this summer.

At the ESC heart failure meeting this weekend Entresto investigators will also deliver some supporting secondary information about the drug. Most importantly, an analysis of dementia adverse events in the pivotal PARADIGM-HF trial finds no signal for any increase in the risk of dementia among patients who received Entresto compared to control patients receiving enalapril. Using strict criteria to identify dementia the investigators identified 15 cases (0.35%) in the Entresto group versus 12 cases (0.29%) in the enalapril group (p=ns). Applying broader criteria they identified 83 cases (1.96%) in the Entresto group and 86 cases (2.05%) in the enalapril group (p=ns).

As I’ve written previously, the possibility that Entresto might increase the risk of dementia has been the single biggest overhang for the drug. The new data would appear to put that concern to rest, at least temporarily. Certainly there’s no reason to think it could prevent the drug’s launch. But the long term risk remains. Dementia was not rigorously monitored in PARADIGM. The next big study, PARAGON, includes much more rigorous neurocognitive assessments, including monitoring patients for amyloid on imaging and for cognitive decline, according to Bernstein analyst Timothy Anderson. As I wrote previously, it’s much easier to find a signal for a problem that you are specifically looking for than if you are just generally trying to monitor adverse events.

One other paper coming out this weekend deserves mention. The PARADIGM investigators performed a complex statistical analysis to estimate the long-term treatment benefits of Entresto. Given the significant reduction in mortality in the trial, it should come as no surprise that the investigators now estimate that the drug will produce an increase in overall survival of 1.4 years for a typical 55-year old patient and 1.3 years for a typical 65-year old patient. As would be anticipated, the effect diminishes as patients get older.

Source: Forbes