- Cancer Biology & Biomarkers
- Chromatography & Mass Spectrometry
- Contract Research, Clinical Trials and Outsourcing
- Drug Discovery
- Drug Targets
- Flow Cytometry
- Informatics & Lab Automation
- Ingredients, Excipients and Dosages
- Microbiology & RMMs
- NIR, PAT & QbD
- Raman Spectroscopy
- Screening, Assays & High-Content Analysis
- Thermal Processing
- Events & Workshops
EC grants marketing authorisation to Entresto
25 November 2015 • Author: Victoria White
The European Commission has granted marketing authorisation to Novartis’ Entresto (sacubitril/valsartan) for the treatment of adult patients with symptomatic chronic heart failure with reduced ejection fraction (HFrEF).
Entresto is a twice-a-day tablet and has a unique mode of action, which is thought to reduce the strain on the failing heart.
The authorisation is based on results from the 8,442-patient PARADIGM-HF study in patients with HFrEF, which was stopped early when it was shown Entresto significantly reduced the risk of cardiovascular death versus ACE-inhibitor enalapril. At the end of the study, Entresto was superior to enalapril in reducing the risks of mortality and of hospitalisation for heart failure. Analysis of safety data showed that Entresto had a similar tolerability profile to enalapril.
Novartis working with NICE and SMC to make Entresto available in the UK
“Heart failure is a potentially life-threatening condition that has a major impact on patients and their carers,” said Dimitrios Georgiopoulos MD, Chief Scientific Officer, Novartis Pharmaceuticals UK Ltd. “There is a real need for new and effective treatments that reduce mortality and morbidity while improving patients’ quality of life. Sacubitril/valsartan is a new first-in-class treatment option for heart failure patients with reduced ejection fraction that demonstrated a significant mortality benefit, including reducing the risk of sudden death versus, the current standard of care.”
Novartis has said it is currently preparing for Entresto to be available in the UK before the end of 2015. Since September 2015, the therapy has been available to patients under the Early Access to Medicines Scheme (EAMS). Novartis is working with NICE and the Scottish Medicines Consortium (SMC) to ensure as many eligible patients as possible will be able to benefit from the drug once it has been appraised.
ABB Analytical Measurement ACD/Labs ADInstruments Ltd Advanced Analytical Technologies GmbH Analytik Jena AG Astell Scientific Ltd B&W Tek Bachem AG Bibby Scientific Limited Bio-Rad Laboratories BioNavis Ltd Biopharma Group Black Swan Analysis Limited Butterworth Laboratories Ltd CAPSUGEL NV Charles Ischi AG | Kraemer Elektronik Cherwell Laboratories CI Precision Cobalt Light Systems Coulter Partners CPC Biotech srl Dassault Systèmes BIOVIA DiscoverX Edinburgh Instruments Enterprise System Partners (ESP) Eurofins BioPharma Product Testing EUROGENTEC F.P.S. Food and Pharma Systems Srl GE Analytical Instruments IDBS JEOL Europe Kaiser Optical Systems Inc. L.B. Bohle Maschinen + Verfahren GmbH Lab M Ltd. LabWare Linkam Scientific Instruments Limited MA Business Metrohm Molins Technologies Multicore Dynamics Ltd Nanosurf New England Biolabs, Inc. Ocean Optics Panasonic Biomedical Sales Europe B.V. PerkinElmer Inc ReAgent Russell Finex Limited Source BioScience Takara Clontech Tornado Spectral Systems Tuttnauer Viavi Solutions, Inc Watson-Marlow Fluid Technology Group Wickham Laboratories Limited Xylem Analytics YMC Europe GmbH Yusen Logistics