Novartis sees the positives in flopped Entrestro heart failure study

Novartis had set high hopes for its Entrestro cardiovascular medication, with the company forecasting peak sales of $5bn. Now a huge trial setback has forced Novartis to lower its lofty expectations. But Novartis have not completely written of the drug, citing there is positive news as it was only a ‘narrow miss.’

Entresto reduced the combined rate of heart failure hospitalizations and cardiovascular death among heart patients by 13% according to the data from the phase three trial. However this reduction failed to meet any statistical significance.

Entresto narrowly missed its primary end-point, but the drug still showed improvements in patient quality of life as well as strong results in particular patient subgroups such as patients with a left ventricular ejection fraction equal to or below the median of 57%.

David Soergel, Novartis’s head of cardiovascular renal and metabolic drug development stated: “What we see in the data is clear evidence that Entresto has drug effects and potentially beneficial effects just based on the totality of the data.”

Despite the setback, Entresto has seen a huge surge in sales in the last few months, including the $1.08bn hit in 2018, after a slow response after its 2015 approval. Novartis had high hopes the drug would become a cash cow predicting sales of $5bn. In the second quarter, Entresto posted a quarter over quarter sales jump of 81% to hit $421m.

However, Entresto is one of many cardiovascular flops for Novartis, as the FDA rejected another candidate to treat patients with prior heart attacks. In that particular case, the FDA rejected the approval after acquiring more data from the drugs phase three trial.

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