‘Entresto’ Recommended For Approval by European Medicines Agency's Review Body
Novartis AG, a Swiss multinational pharmaceutical company based in Basel, Switzerland, revealed that its new heart failure drug, Entresto, has been recommended for approval in Europe by the European Medicines Agency's review body.
The decision made by Committee for Medicinal Products for Human Use has send Entresto more closer to get approval for heart failure and reduced ejection fraction (HFrEF) patients across Europe by year-end, the company said.
Entresto, which is also known as LCZ696, is the first new drug in decades that claims to help patients whose lives are in danger because their hearts cannot pump blood efficiently. The drug is expected to be one of the biggest new drugs launched in 2015.
As per the prediction made by analysts, the drug will help the company to make several billion dollars in sales.
The heart failure medicine received approval from the Swiss medicines devices authority Swissmedic last week after receiving early approval from the US food and Drug Administration in July.
If Entresto gets final approval, it will be available for the treatment of adult patients with symptomatic chronic HFrEF, the company said.
During its trials, Entresto showed that it can reduce the risk of cardiovascular death and first-time hospitalizations due to heart failure by a fifth over a widely used generic medicine.
Entresto was studied in world's largest heart failure trial which was stopped early seeing the strength of results that showed a 20% cut in cardiovascular deaths vs enalapril.
David Epstein, Division Head, Novartis Pharmaceuticals, said, "With the poor prognosis heart failure patients face - only half will be alive 5 years from diagnosis - the CHMP's endorsement of Entresto brings hope for HFrEF patients in Europe".