‘Game-changing’ heart failure drug to be fast-tracked
The novel heart failure drug LCZ696 – labelled a ‘game changer’ in heart failure treatment by GP experts – could be available for GPs to prescribe as soon as September next year.
The European Medicines Agency confirmed that the drug – a combination of the neprilysin inhibitor sacubitril and the ARB valsartan – has been granted ‘accelerated assessment’, shortening the drug approval period from the usual 210 to 150 days.
According to Novartis, the company that is developing LCZ696, this means the drug could receive marketing authorisation as early as September next year.
Treatment with LCZ696 was shown to significantly reduce cardiovascular deaths and heart failure hospitalisations when compared with ‘gold-standard’ treatment with enalapril, in the pivotal PARADIGM-HF trial reported at the European Society of Cardiology earlier this year.
GP experts told Pulse at that time that, if approved, drug could be a ‘game changer’ in the management of heart failure, because it appears to be so much more effective than established treatments.
The EMA told Pulse accelerated assessments may be granted to new drugs if ‘the medicine is expected to be of major public health interest particularly from the point of view of therapeutic innovation’.
Once the EMA’s Committee for Human Medicine Products (CHMP) has made a decision on whether the drug should be approved, the European Commission can grant marketing authorisation within 67 days, which Novartis said means the drug could be marketed as soon as September 2015, instead of the end of 2015 or early 2016.
A spokesperson for Novartis told Pulse: ‘With the accelerated CHMP, Marketing Authorisation for LCZ696 is expected to be in either September 2015 (earliest date possible) or October 2015.’
Even with EU marketing approval, GPs may not be able to prescribe the drug on the NHS until it is appraised and recommended by the UK health regulator NICE – although NICE’s process could start before the drug gains marketing authorisation, if requested.
NICE told Pulse it has not received a request to appraise LCZ696, but would aim to produce final guidance within four to six months of the drug being granted marketing authorisation.
A NICE spokesperson said: ‘The appraisal process can start before a drug receives its marketing authorisation but the production of draft guidance does depend on marketing authorisation being granted.’