Novartis AG's new heart failure drug Entresto is on track to be approved for use in Europe by the end of the year after it received the backing of EU regulators, the company said on Friday.
Entresto, also known as LCZ696, is the first new drug in decades for helping patients whose lives are in danger because their hearts cannot pump blood efficiently. Analysts estimate it could have annual sales of some US$4.4 billion by 2020.
Basel-based Novartis said it is waiting for final approval from the European Commission before setting a price for the drug.
"Prices in countries in Europe will be confirmed after EC approval and will be determined according to local pricing and reimbursement regulations, submissions and evaluation processes," Novartis spokesman Dermot Doherty said in an email.
Entresto won approval in Switzerland last week and got a green light from the US Food and Drug Administration in July.
Pending final approval by the European Commission, Entresto will be available for the treatment of adult patients with
symptomatic chronic reduced ejection fraction (HFrEF), the company said.
In trials, Entresto showed that it reduced the risk of cardiovascular death and first-time hospitalizations due to heart failure by a fifth over a widely used generic medicine.
Novartis shares were up 3.85 percent by 1020 GMT (6:20 a.m. EDT), outpacing rival Roche's 2.45 percent gain in a broadly firmer Swiss stock market.
"This is good news," Bank Vontobel analyst Stefan Schneider said in a note to investors. He said it was widely expected by the market after trials that showed the drug cut the risk of death by 20 percent. Schneider anticipates European Commission approval by year-end.
Novartis is looking to Entresto to help revive its fortunes in heart medicine as the blood pressure pill Diovan – a major source of the company's profits in the past – faces competition from generics.