Novartis’ new heart failure treatment Entresto (ingredient: sacubitril/valsartan) may have to fight against Boehringer Ingelheim’s diabetes drug Jardiance (empagliflozin).
Having different indication from each other, the two drugs have not had any overlapping market so far but will do so from next year. Novartis won approval for Entresto from the U.S. Food and Drug Administration as the first treatment for chronic heart failure in 2015.
According to the PARADIGM-HF trial that tested Entresto’s efficacy and safety in 8,442 patients with heart failure with reduced ejection fraction (HFrEF) who have left ventricular systolic dysfunction, the drug reduced the risk of cardiovascular death, hospitalization for heart failure, and progress of the disease.
In the treatment of heart failure, Entresto’s arrival in the market drew much attention because there was no other option than angiotensin-converting-enzyme inhibitors. In the second quarter, Entresto’s sales surged 76 percent to $421 million.
Novartis has been conducting the Paragon-HF study since 2014 to expand Entresto’s target patients to heart failure patients with preserved ejection fraction (HFpEF), estimated to be about 13 million worldwide.
However, the company announced Monday last week that Entresto failed to prove efficacy in HFpEF in the Paragon-HF trial. There is no approved treatment for HFpEF patients.
|Boehringer Ingelheim’s diabetes drug Jardiance (left) and Novartis’ heart failure treatment Entresto|
Novartis’ latest trial failure is not the only bad news for the company’s growth prospect. Sodium-glucose transport protein 2 (SGLT-2) inhibitors, rising as antidiabetic drugs, are also showing signs of becoming a heart failure treatment to compete against Entresto.
Among SGLT-2 inhibitors, Boehringer Ingelheim’s Jardiance is the most likely medicine to put pressure on Entresto.
The FDA recently gave Jardiance the fast track status for review as a chronic heart failure treatment. Jardiance is going through the EMPEROR trial to check efficacy to treat heart failure in both patients with HFrEF and HFpEF.
The trial compares Jardiance’s effectiveness and safety with those of enalapril in more than 8,500 patients with chronic heart failure (5,250 with HFpEF, 3,600 with HFrEF). The company expects to complete the evaluation next year.
If Jardiance proves its potency in improving cardiovascular death and hospitalization for heart failure, it will be the most significant hurdle for Entresto’s growth. Physicians have already prescribed Jardiance as a diabetes drug much and it is affordable, compared to Entresto.
In Korea, Entresto, taken twice a day, is priced at 2,243 won ($1.85), the same in all dosages per tablet, under the insurance coverage. However, Jardiance 10mg, taken once daily, is 660 won per tablet. Jardiance is three times cheaper than Entresto. If Jardiance obtains expanded indication for patients with HFpEF, it will hurt Entresto’s sales.
Cardiovascular studies in diabetic patients have already shown that SGLT-2 inhibitors can prevent heart failure. Not only Jardiance but most SGLT-2 inhibitor sellers are working on trials to prove efficacy in the treatment of heart failure.
The FDA picked Jardiance only to have the fast track review status, as its clinical design was the best to prove effectiveness, and it was likely to yield an outcome.
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