PARIS (awp / afp) – Praluent, a drug marketed by French group Sanofi and its partner Regeneron cholesterol, has been approved by the US Drug Administration (FDA) to reduce the risk of cardiovascular disease. according to a statement published on Saturday.
The Drug Administration has approved the United States "for adults with cardiovascular disease," said the document "for the prevention of heart attack, stroke and angina (risk and angina pectoris)".
This drug "causes all causes to reduce significantly the death rate," he says.
The support of the Drug Agency "is a major breakthrough in the treatment of those with cardiovascular disease, and therefore, due to serious cardiovascular events, they are at greater risk of death or disability," Dr. John Reed, Sanofi's global leader in research and development.
The results of a study that reduced the general risk of heart attack, stroke, coronary artery disease, and the general risk of hospitalization at angina home. Patients with pralentia.
However, the total death risk decreased by 15% in the case of these patients.
The Odyssey results study was conducted almost three years ago with about 19,000 patients from 57 countries and some of them up to five years.
Praluent, jointly developed by Sanofi and Regeneron, neutralizes the protein that prevents the removal of bad cholesterol, with different statin mechanisms.
More than 60 countries have been approved, such as the European Union, the United States and Japan.
It is also a matter for the courts. Amgen's US Laboratory, Sanofi and Regeneron, has accused her drug of violating Repatha's patent for developing her Praluent competitor.
VAC / SOE / mcj