Novartis heart drug steps closer to EAMS scheme
pharmafile | April 23, 2015 | News story | Sales and Marketing | LCZ696, MHRA, Medicines and Healthcare products Regulatory Agency, NICE, eams, pim, sacubitril/valsartan
Novartis’ investigational heart failure drug LCZ696 has been handed a Promising Innovative Medicine designation (PIM) after showing that it significantly improves patient outcomes compared to the current gold standard treatment.
LCZ696 (sacubitril/valsartan) is the first non-oncology medicine to receive this designation, and now has covered one out of two steps to be included into the Early Access to Medicines Scheme (EAMS).
EAMS was launched last year with the aim of giving patients with life threatening conditions access to medicines which are currently not approved by any marketing authorisation. It is overseen by the Medicines and Healthcare products Regulatory Agency (MHRA).
In a recent Phase III study the investigational medicine showed a reduction in cardiovascular deaths by 20%, and during trials reached its secondary and primary endpoints.
Hugh O’Dowd, who is the general manager at Novartis UK & Ireland, says: “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.
“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.”
LCZ696 is an inhibitor displaying a mode of action which is thought to reduce the strain of a failing heart by harnessing the body’s natural defences against the condition.
Heart failure is a debilitating and life-threatening disease in which the heart cannot pump enough blood around the body. Symptoms include breathlessness, fatigue and fluid retention which can all worsen over time.
Approximately 14 million people suffer from heart failure in Europe and nearly six million are affected in the US. The condition consumes almost 2% of the NHS budget in the UK which equates to approximately £1.9 billion.
Novartis’ heart pill was also handed a similar designation earlier this year by the US Food and Drug Administration when it granted the drug a priority review.
Tom Robinson
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