Investigational heart failure medicine LCZ696 (sacubitril/valsartan) receives Promising Innovative Medicine designation in the UK
· PIM designation is the first step to inclusion in the Early Access to Medicines Scheme (EAMS), providing patients with faster access to innovative medicines
· LCZ696 is the first non-oncology medicine to receive this designation since the scheme's inception in April 2014
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[i].
[i] NICE. Clinical Guideline. Chronic heart failure. Available online at http://guidance.nice.org.uk/CG108 Accessed April 2015