The timing of the FDA’s approval was a surprise because Novartis was expecting to receive it in August. The FDA decision follows the Paradigm-HF study, involving 8,442 patients, which also closed ahead of schedule because of the excellent preliminary results, said the pharmaceutical giant.
In a statement, the FDA stressed that the test results have shown that Entresto reduced the rate of death and cardiovascular hospitalization related to heart failure and could lengthen the life expectancy of patients, allowing them to live more active lives.
Heart disease affects nearly six million Americans, said the Swiss pharmaceutical giant.
Novartis expects to start delivering Entresto in the United States next week. The drug will be prescribed to patients to prevent the risk of heart attack or hospitalizations related to heart failure. Normally it will be prescribed in conjunction with other therapies.
The new drug is likely to be very popular in the market and a consensus of Thomson-Reuters sector analysts expect annual sales of US$4.4 billion by 2020.
Entresto is the first drug launched for decades to help patients whose hearts can no longer pump blood efficiently throughout the body. As such, it is slated to be one of the pharmaceutical industry’s highlights for 2015.