Injection
France's Sanofi and US partner Regeneron Pharmaceuticals have announced that the phase 3 trial of drug Praluent reduced cholesterol in 69% of Japanese patients in a phase 3 trial.
The trial involved 216 Japanese patients with hypercholesterolemia at high cardiovascular risk and/or with an inherited form of high cholesterol known as heterozygous familial hypercholesterolemia.
Lead investigator and director of Teikyo Academic Research Center, said: "These results demonstrate the significant cholesterol-lowering ability of Praluent among patients with some of the greatest unmet needs in Japan. This includes those with an inherited form of high cholesterol or pre-existing cardiovascular disease, such as a history of heart attack."
The Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) of the US Food and Drug Administration (FDA) has recommended the approval of Praluent.