Armed with positive new data, Novartis has said it plans to submit its much-anticipated new drug for chronic heart failure – LCZ696 – before the end of the year in the US.
The company will unveil new results from the large-scale PARADIGM-HF of LCZ696 at the European Society of Cardiology (ESC) conference later this month that it says reinforce its benefits in reducing cardiovascular deaths in patients with heart failure and reduced ejection fraction (HF-REF).
Earlier this year the 8,442-patient study – the largest ever conducted in heart failure – was called to a halt after it became clear that LCZ696 was much better than the angiotensin-converting enzyme (ACE) inhibitor enalapril in keeping patients alive and out of hospital.
Since then, additional analyses from the trial have been carried out to see if Novartis drug, which is the lead candidate in a new class called the angiotensin-receptor neprilysin inhibitors (ARNIs), could supplant ACE inhibitors as a keystone of heart failure treatment.
As well as updated survival data, Novartis will present new safety data at the ESC which shows that LCZ696 was well-tolerated, with manageable side effects. It will provide additional data on the relative risk reduction for LCZ696 against the active comparator and has indicated is also planning to host a conference call with investors to discuss the data in more detail.
LCZ696 was recently granted FDA Fast Track status and a rolling submission is expected to be complete by end of year, said the company in a statement.
The rolling submission in the US “will start in October and wrap up by December of this year and that will be followed by an EU submission in the first quarter of 2015,” said Novartis’ chief executive Joe Jimenez.
The ARNI has also shown promise as a treatment for high blood pressure, outperforming Novartis’ angiotensin receptor blocker (ARB) valsartan in a trial reported in 2010, and has also shown some evidence of efficacy in heart failure patients with preserved ejection fraction, a group accounting for around half of all heart failure patients which has few effective treatment options at present.
LCZ696 combines valsartan with an enzyme blocker called neprilysin, which boosts the activity of natriuretic peptides that can alleviate heart failure and some signs of cardiomyopathy.
The emerging clinical profile for the drug suggests it could become broadly used in cardiovascular medicine, and has helped drive analyst predictions that it could be used to treat millions of patients and achieve $5bn a year in peak sales if it reaches the market.
Novartis was less successful in its efforts to secure approval of acute heart failure therapy Reasanz (serelaxin), which was rejected by an FDA advisory committee earlier this year because of a lack of clinical evidence to support its efficacy.
Novartis is currently conducting a second phase III trial of Reasanz which has mortality as a primary endpoint that it hopes will support approval.