FDA Grants Priority Review for Novartis’ Heart Drug
Novartis reports that the US Food and Drug Administration (FDA) has granted priority review designation to LCZ696, an investigational medicine for the treatment of heart failure with reduced ejection fraction (HFrEF). The designation accelerates the review of therapies that offer a significant improvement in the safety or effectiveness of the treatment, prevention or diagnosis of a serious condition. For LCZ696 this reduces the total review time from 12 to 8 months, meaning the FDA could make a decision on approval in August 2015.
The new drug application (NDA) was submitted under the agency’s Fast Track program. In the European Union, the Committee for Medicinal Products for Human Use (CHMP) has granted accelerated assessment to LCZ696.
LCZ696, a twice-a day medicine being investigated for heart failure and has amode of action which is thought to reduce the strain on the failing heart. It acts to enhance the protective neurohormonal systems of the heart (NP system) while simultaneously suppressing the harmful system (the RAAS). Currently available medicines for HFrEF primarily block the harmful effects and mortality remains very high with up to 50% of patients dying within five years of a diagnosis of heart failure, according ot information from Novartis.