(Bloomberg) — Amgen Inc.’s cholesterol drug was recommended for approval by the European Union’s drug regulator.

The medicine, called Repatha, was endorsed by a European Medicines Agency panel as a treatment for patients with high cholesterol that can’t be controlled by statins alone, or who can’t take statins, the regulator said Friday in a statement. The drug hasn’t been approved yet by the U.S. Food and Drug Administration.

Amgen, based in Thousand Oaks, California, will be competing with Sanofi and Regeneron Pharmaceuticals Inc., which have co-developed a similar drug. Amgen has said the potential patient population for Repatha exceeds 25 million, and analysts expect the injections to generate blockbuster sales.