Investigational heart failure medicine LCZ696 receives PIM designation in the UK

Novartis is delighted to announce that the Medicines and Healthcare products Regulatory Agency (MHRA) has granted a Promising Innovative Medicine (PIM) designation for its investigational medicine for patients with heart failure (HF) with reduced ejection fraction, LCZ696 (sacubitril/valsartan).

Novartis is delighted to announce that the Medicines and Healthcare products Regulatory Agency (MHRA) has granted a Promising Innovative Medicine (PIM) designation for its investigational medicine for patients with heart failure (HF) with reduced ejection fraction, LCZ696 (sacubitril/valsartan).

The PIM designation is the first step towards inclusion in the EAMS, a UK scheme run by the MHRA, that aims to give patients with life-threatening conditions access to specified pre-licence medicines when there is a clear medical need. LCZ696 has been awarded the PIM designation based on the results of the PARADIGM-HF trial, which showed that LCZ696 significantly improved patient outcomes compared to the current gold standard treatment, including a reduction in cardiovascular deaths. Today, around 900,000 people in the UK live with HF and HF hospital admissions are projected to rise by 50% over the next 25 years. (1)

Hugh O’Dowd, General Manager at Novartis UK & Ireland, commented on the announcement: “Despite widespread use of available treatments and implementation of NICE heart failure guidelines, outcomes remain poor for those diagnosed, with around 60% dying from heart failure within five years.2 It is therefore very encouraging that LCZ696 has been recognised as a scientific innovation that can improve the lives of people living with this debilitating condition.”

The EAMS, part of the Government’s Strategy for UK Life Sciences, aims to ensure the UK is a world leader in life sciences and improve the wider environment for health life sciences companies. The Government believes that a successful and competitive UK life sciences sector can improve the lives of UK patients, increase efficiency in the NHS and benefit the UK economy.

References:

1. NICE. Clinical Guideline. Chronic heart failure. Available online at http://guidance.nice.org.uk/CG108 Accessed April 2015.
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