Novartis heart failure drug available via EAMS
pharmafile | September 3, 2015 | News story | Sales and Marketing |Â Â Early Access to Medicines Scheme, Entresto, LCZ696, MHRA, Novartis, eams, heart failure, sacubitril/valsartanÂ
Novartis has won the investigational heart failure treatment LCZ696 (sacubitril valsartan) will be available in the UK under the Early Access to Medicines Scheme (EAMS).
The treatment has been given a positive scientific opinion by the Medicines and Healthcare products Regulatory Agency (MHRA), under its Early Access to Medicines Scheme (EAMS). The scheme is designed for patients with significant unmet medical need, allowing it to be made available to eligible patients before a final European licensing decision is made.
It is the first time non-oncology drug has been recognised under EAMS, and follows its approval in the US earlier this year, where it is available under the brand name Entresto. In another MHRA decision, AstraZeneca’s investigational lung cancer drug AZD9291 was awarded Promising Innovative Medicine status, the first step towards acceptance in the scheme.
Heart failure affects around 550,000 people in the UK and costs the NHS about £2.3 billion a year. It also has a poor prognosis, with around 60% of patients diagnosed with the condition dying within five years, and survival rates are worse than certain cancers, including breast and prostate.
The MHRA gave 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 the treatment 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, says: “Despite widespread use of available treatments and implementation of NICE guidelines, outcomes remain poor for those diagnosed with heart failure. So it’s 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.”
Iain Squire, professor of cardiovascular medicine at the University of Leicester and honorary consultant physician at University Hospitals of Leicester NHS Trust, comments: “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. Based on what we’ve 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.”
Life Sciences Minister George Freeman adds: “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.”
Joel Levy
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