The US Food and Drug Administration will undertake a speedy review of Novartis’ closely-watched heart failure drug LCZ696, cutting the total review time from 12 months to eight.
The move signals that the US regulator believes the drug could offer a significant improvement over existing therapies, and means that Novartis should have a decision in August at the latest.
A twice daily pill, LCZ696 has a unique mode of action thought to reduce the strain on the failing heart, by enhancing its protective neurohormonal systems while simultaneously suppressing the harmful ‘RAAS’ one.
Industry observers believe it has the potential to revolutionise heart failure treatment; data presented at the European Society of Cardiology meeting in Barcelona last August showed that LCZ696 cut cardiovascular deaths by 20% versus the ACE-inhibitor enalapril.
Nearly six million people live with heart failure in the US, but despite current therapies, up to 50% of patients die within five years of diagnosis.
European regulators are already undertaking an accelerated assessment of LCZ696.