US FDA approves Novartis' combo heart failure drug Entresto ahead of schedule

The US Food and Drug Administration yesterday approved Entresto (sacubitril/valsartan) tablets for the treatment of heart failure, marking the first ever approval of the drug and some six weeks ahead of the FDA’s priority review date.

The combination drug, previously known as LCZ696, from Swiss pharma giant Novartis (NOVN: VX), has been shown to reduce the rate of cardiovascular death and hospitalization related to heart failure, noted the FDA, pointing out that heart failure is a common condition affecting around 5.1 million people in the USA. Novartis’ shares move 1.7% higher to 94.00 Swiss francs in early trading this morning.

Entresto was reviewed under the FDA’s priority review program, which provides for expedited review of drugs that are intended to treat a serious disease or condition and may provide a significant improvement over available therapy, the agency noted. It was also granted fast track designation, which supports FDA’s efforts to facilitate the development and expedite the review of drugs to treat serious or life-threatening conditions and fill an unmet medical need.