Novartis’ LCZ696 gains PIM designation in UK

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted a Promising Innovative Medicine (PIM) designation for Swiss pharma giant Novartis’ (NOVN: VX) 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 Early Access to Medicines Scheme (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.

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.”