Novartis’ heart failure candidate LCZ696 has become the first cardiovascular drug to get an accelerated review in the EU.
The European Medicines Agency (EMA) rarely uses its accelerated assessment procedure – which reduces review time from 210 days to 150 days – but agreed with Novartis that LCZ696 should be fast-tracked.
The truncated review is intended for “medicinal products of major interest from the point of view of public health and in particular from the view point of therapeutic innovation,” according to the EMA.
Given Novartis expects to file for approval of LCZ696 in early 2015, the decision by the Committee for Medicinal Products for Human Use (CHMP) means the drug could be on the market before the end of that year.
Novartis plans to file for approval of LCZ696 a little earlier in the US – before the end of the year – and says the drug has also been granted fast-track designation by the FDA, which also awarded the drug breakthrough status in 2013.
Novartis reported impressive new data from the PARADIGM-HF study of LCZ696 at the European Society of Cardiology (ESC) meeting in September, revealing that the drug doubled the survival benefit seen with standard therapy based on the ACE inhibitor enalapril in patients with heart failure and low ejection fraction.
Adding LCZ696 reduced cardiovascular deaths by 20% and all-cause mortality by 16% compared to enalapril, which had previously been shown to improve survival by 15% in these patients.
The results prompted predictions of blockbuster sales for Novartis’ drug, which is a combination of the angiotensin II receptor antagonist valsartan with a neprilysin blocker called sacubitril that boosts its effects in the body.
Deutsche Bank said the data were compelling enough to persuade cardiologists to switch heart failure patients from ACE inhibitors to LCZ696, and – if additional indications in heart failure are approved – could lead to peak sales of up to $10bn.
Specifically, that estimate is based on LCZ696 also showing a benefit in patients with heart failure and preserved ejection fraction, which is being tested in a separate study. Meanwhile, other analysts are more reticent, but a number have predicted peak sales in the $3bn-$7bn range, particularly as no other company is close to market with an angiotensin receptor/neprilysin inhibitor combination.
“Novartis is committed to extending and improving more lives sooner with LCZ696, and this decision by the CHMP we hope will greatly support our effort to do so in Europe,” said David Epstein, who heads Novartis’ pharmaceuticals division.
Approximately 26 million people in the US and EU live with heart failure, facing a high risk of death and poor quality of life despite currently available medicines, according to Novartis.