Entresto’s sales exceeded KRW 40 billion last year

Continues its unceasing growth

Outpatient prescriptions recorded KRW 40.6 billion last year, a 26% rise from the previous year

Has recorded growth every quarter since its release in Q4 2017

Various attempts at its combined use with other class drugs are being actively made...including various class drugs for heart failure, etc.

Pic of Entresto

Sales of Novartis Korea’s chronic heart failure treatment ‘Entresto’ has exceeded KRW 40 billion 6 years into its release.

 

According to market research institution UBIST on the 7th, Entresto’s outpatient prescription sales had recorded KRW 40.6 billion last year.

 

This is a 26% increase from the KRW 32.3 billion it had recorded the previous year.

 

Entresto is a first-in-class angiotensin receptor-neprilysin inhibitor (ARNI) that combines the angiotensin receptor blocker (ARB) 'valsartan' and neprilysin inhibitor 'sacubitril.' The drug may be used as an alternative to an angiotensin receptor blocker (ARB) or an angiotensin-converting enzyme (ACE) inhibitor in patients with left ventricular (LV) dysfunction as an alternative to other heart failure treatments.

 

Entresto received marketing authorization in April 2016 and the drug was officially launched with reimbursement in October 2017.

 

Although the drug recorded KRW 6.3 billion in its first year of release in 2018, its sales surged to KRW 15 billion in 2019, KRW 23.5 billion in 2020, then exceeded KRW 30 billion and recorded KRW 32.3 billion in 2021.

 

Data: UBIST

The drug’s quarterly sales first exceeded KRW 10 billion for the first time last year.

 

Last year, Entresto raised sales of KRW 9.1 billion in Q1, then KRW 9.6 billion in Q2, then KRW 10.5 billion in Q3.

 

In Q4, its sales continued to rise to record KRW 11.4 billion in Q4 last year.

 

Entresto made explosive growth demonstrating its superior efficacy in heart failure with reduced ejection fraction (HFrEF).

 

Entresto replaced the ACE or ARB inhibitors that had been mainly used in these patients.

 

In HFpEF, no suitable treatment exists other than Entresto.

 

Entresto may be used in patients with a left ventricular ejection fraction of 40% or higher to 60% (below normal level).

 

Based on the evidence, the Korean Society of Heart Failure (KSHF) recommended Entresto as a priority treatment in HFrEF, and as a Class IIa, Level of Evidence B in heart failure with mildly reduced EF and heart failure with preserved ejection fraction in the newly revised clinical practice guidelines last year.

 

Recently, Novartis released large-scale real-world trial data on Entresto that was conducted on Korean patients, increasing evidence on the efficacy and safety of the drug.

 

Results of the study that was conducted on a total of 600 patients from 2017 to 2019 showed that patients first started treatment with the initial 50-100 mg bid dose and maintained or stably increased the dose for 12 and reached target dose.

 

The trial results addressed the concerns on how the target dose of Entresto was difficult to administer due to concerns over hypotension.

 

Of the total patients, about 40% maintained their dose of Entresto, and 42% stably increased their dose.

 

SGLT-2 inhibitors, which were previously used as diabetes drugs, had expanded their scope to treating heart failure.

 

Although new drugs with new mechanisms of action have also been introduced to the market, Entresto's growth is expected to continue for the time being as newly introduced drugs have a different mechanism of action, and various attempts at its combined use with other class drugs are expected to be made.

 

Domestic companies have been continuing their attempts to challenge Entresto that had emerged as a blockbuster drug.

 

Domestic pharmaceutical companies, starting with Hanmi Pharmaceutical, followed by Chong Kun Dang, Samjin Pharm, Hana Pharm, and Ahn-Gook Pharmaceutical, filed suits to avoid all four patents related on Entresto.

 

Last year, Hanmi Pharmaceutical was the first to succeed in avoiding all 4 patents related to Entresto.

 

Since then, 9 more companies have succeeded in avoiding the patents.

 

In other words, the generic companies have all won the first trial.

 

Novartis appealed to the results of the first trial, and the second trial is currently in progress.