Novartis convinced the FDA last week to grant Entresto (sacubitril/valsartan) a label expansion to include heart failure with preserved ejection fraction (HFpEF) despite the drug coming agonisingly close but falling short in the Phase III PARAGON-HF trial. The drugmaker will now take its case to a prescriber base that is both slow to embrace change but desperate for options for an indication that has proven notoriously intractable.
To provide FirstWord readers with rapid feedback on use of Entresto and the treatment of HFpEF, we are hosting an expert call with a key opinion leader (KOL) this week.
Key topics that will be discussed during the call include, among other things… how are you currently managing patients with HFpEF; how impressed are you by Entresto’s performance in PARAGON-HF; what stands out most about the dataset and/or the drug’s profile in HFpEF; if you were on the AdCom, would you have recommended approving the label extension; the wording of Entresto’s new label is a bit nebulous so how (and how often) do you think it will be prescribed for patients with an ejection fraction higher than 40%; what proportion of the heart failure population with ejection fraction of 57% or below would you prescribe Entresto to; how quickly will use ramp up in the HFpEF setting; cardiologists are historically slow to embrace new drugs but will their experience with Entresto thus far help facilitate adoption; and are there any therapies in clinical trials for HFpEF that look especially promising?
Ask the expert!
Furthermore, we invite FirstWord Pharma readers to submit their own questions for consideration. Please click here to do so. We can't guarantee that all questions submitted will be asked due to time constraints, but we will do our utmost to cover the important issues relating to use of Entresto and/or the treatment of HFpEF.
We endeavour to provide feedback from KOLs as quickly as possible. Interview content will be published for FirstWord Pharma PLUS subscribers to read. To be notified when the interview content is available please click here.
As always, FirstWord Pharma would very much like to receive your feedback and suggestions.
To read more KOL Views articles, click here.