Sanofi, Regeneron say Japan study shows Praluent drug lowers cholesterol

PARIS, July 9 (Reuters) - French drugmaker Sanofi and U.S. partner Regeneron said the results of a late-stage study of their Praluent injection in Japan showed the drug reduced "bad cholesterol" among patients by an average 64 percent.

The trial involved 216 Japanese patients who had one or both of hypercholesterolaemia, a cholesterol condition with associated high cardiovascular risk, and an inherited form of high cholesterol, the companies said in a statement on Thursday.

"These results demonstrate the significant cholesterol-lowering ability of Praluent among patients with some of the greatest unmet needs in Japan," lead investigator Tamio Teramoto, director of Teikyo Academic Research Center, said in the statement.

"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 of the U.S. Food and Drug Administration (FDA) recommended the approval of Praluent on June 9, Sanofi said. The FDA considers the committee's advice but is not bound by it.

The European Medicines Agency is currently reviewing a marketing application for the drug in the European Union.

(Reporting by James Regan; Editing by Kenneth Maxwell)

Advertisement