Novartis has announced that its investigational heart failure treatment LCZ696 (sacubitril valsartan) has been given a positive scientific opinion under the Medicines and Healthcare products Regulatory Agency (MHRA) Early Access to Medicines Scheme (EAMS) for patients with significant unmet medical need. This allows LCZ696 to be made available to eligible patients before a final European licensing decision is made.
It is the first time a drug not intended to treat cancer has been recognised under EAMS.
“This is great news for patients with heart failure. The EAMS positive scientific opinion ensures patients with this debilitating condition can access sacubitril valsartan earlier than expected,” says Iain Squire, professor of Cardiovascular Medicine, University of Leicester and Honorary Consultant Physician, University Hospitals of Leicester NHS Trust, UK. “Based on what we have seen in clinical trials, access to this new medicine will help patients live longer and keep them out of hospital, compared to currently available treatment.”
The MHRA has given LCZ696 a positive scientific opinion based on the high level of unmet need in heart failure and data from the PARADIGM-HF study that showed LCZ696 significantly improved patient outcomes compared to the current gold standard treatment, including a reduction both in cardiovascular deaths and hospitalisations due to heart failure.
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 is 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.”
Life Sciences Minister George Freeman said: “Heart failure is a devastating condition that affects hundreds of thousands of people in the UK, so I am delighted that patients will now be able to access this life-enhancing treatment. The UK’s Early Access to Medicines Scheme is making a real difference in speeding up access to drugs and almost 300 patients with complex conditions have already received innovative treatments earlier than they otherwise would have thanks to the scheme.”
LCZ696 received FDA approval in July 2015.