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Novartis’ heart failure drug approved via early access scheme

LCZ696 issued positive scientific opinion under EAMS
Novartis Building

Novartis' heart failure medicine LCZ696 has become the first non-oncology treatment to be accepted under the UK's Early Access to Medicine Scheme (EAMS).

The new treatment will therefore be available to eligible patients in the NHS before European regulators officially approve it.

EAMS was launched last year with the hope of giving patients with life-threatening conditions access to medications that are not yet currently approved.

The Medicines and Healthcare products Regulatory Agency (MHRA), which oversees EAMS, issued a positive scientific opinion based on trial data that showed LCZ696 (sacubitril valsartan) was more effective than the current gold standard of treatment.

The phase III trial, known as Paradigm-HF, pitted LCZ696, an angiotensin receptor neprilysin inhibitor (ARNi), against Merck's ACE-inhibitor enalapril.

The findings showed that patients treated with LCZ696 were 20% less likely to die from a cardiovascular cause or hospitalisation and were also 16% less likely to die from any cause.

Novartis had previously estimated peak sales for LCZ696 at $5bn, however some analysts have concluded it could reach $10bn - further warranting its description by Novartis CEO Joe Jimenez as a 'multi-blockbuster'.

Hugh O'Dowd, general manager at Novartis UK & Ireland, said: “Despite widespread use of available treatments and implementation of NICE guidelines, outcomes remain poor for those diagnosed with heart failure. So it's very encouraging that LCZ696 will be available via the EAMS, allowing patients in the UK with this debilitating condition to gain benefit.

“We are working closely with the NHS to ensure eligible patients have rapid access under the scheme while we await the final European licensing decision.”

Heart failure affects around 550,000 people in the UK and costs the NHS roughly £2.3bn a year. Prognosis is still poor, however, as around 60% of patients diagnosed with heart-failure die within five years.

Article by
Nikhil Patel

3rd September 2015

From: Regulatory



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