FDA staff: Sanofi/Regeneron drug lowers LDL; is well tolerated

WASHINGTON, June 5 (Reuters) - A drug made by Sanofi SA and Regeneron Pharmaceuticals Inc effectively lowers bad LDL cholesterol and is generally well tolerated, according to a preliminary review by the U.S. Food and Drug Administration.

The review was published on Friday on the FDA's website before a meeting Tuesday of a panel of outside advisers who will discuss the drug and recommend whether it should be approved.

The FDA is not obliged to follow the advice of its advisory panels but typically does so.

The drug, Praluent, also known as alirocumab, is one of two in a class known as PCSK9 inhibitors that will be considered by the advisory panel next week. The other, Repatha, is made by Amgen Inc.

(Reporting by Toni Clarke in Washington; Editing by Doina Chiacu)

Advertisement