FDA Panel Clears Product Path For Sanofi, Regeneron Pharmaceuticals

A key regulatory advisory panel recommended approval of a cholesterol treatment under joint development by Sanofi SA (ADR) (NYSE: SNY) and Regeneron Pharmaceuticals Inc (NASDAQ: REGN), the companies said Wednesday.

A final ruling is expected July 24 from the Food and Drug Administration, which typically accepts the panel's recommendations.

The injectable treatment, called Praluent, is expected to yield annual sales of $2.5 billion by 2020, according to Thomson Reuters data.

Regeron posted total 2014 sales of $2.82 billion; Sanofi about $34.61 billion.

The same advisory panel meets Wednesday to discuss Amgen, Inc. (NASDAQ: AMGN)'s proposed injectable cholesterol-lowering drug Repatha, also projected to have 2020 sales of $2.5 billion.

Amgen, which posted total sales last year of $20.06 billion, expects a final FDA ruling on Repatha by August 27.

Both Repatha and Praluent are human monoclonal antibodies targeting a specific protein that reduces the liver's ability to remove low-density lipoprotein cholesterol, or "bad" cholesterol, from the blood.

"There remains a significant unmet medical need for patients who, despite currently available therapies, are unable to control their high cholesterol," Amgen researcher Sean E. Harper said.

Most of the advisory panel recommended limiting Praluent to patients predisposed to high cholesterol and at high risk of cardiovascular disease who are on maximum doses of statin therapy, according to Reuters.