Certain patients with heart failure in the UK could get treatment with Novartis’ LCZ696 before it is officially approved by European regulators after the drug was accepted by the Medicines and Healthcare products Regulatory Agency for its Early Access to Medicines Scheme.
Use of LCZ696 (sacubitril valsartan) was cleared for the scheme based on the high level of unmet need in heart failure and data from the Phase III PARADIGM-HF study, which showed that it significantly improved patient outcomes compared to the current gold standard treatment, including a reduction both in cardiovascular deaths and hospitalisations due to heart failure.
Heart failure affects around 550,000 people in the UK and costs the NHS about £2.3 billion a year but, despite widespread use of available treatments, outcomes remain poor with 60% of patients dead within five years of diagnosis.
“The EAMS positive scientific opinion ensures patients with this debilitating condition can access sacubitril valsartan earlier than expected,” said Iain Squire, Professor of Cardiovascular Medicine, University of Leicester and Honorary Consultant Physician, University Hospitals of Leicester NHS Trust. “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.”
It is the first time a drug not intended to treat cancer has been recognised under the EAMS.
US regulators approved LCZ696 as Entresto in July, recognising that it is the first treatment to show a significant mortality benefit over the ACE inhibitor class of medicines.