(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 (FDA).
Amgen (Nasdaq:AMGN), based in Thousand Oaks, Calif., will be competing with Sanofi (NYSE:SNY) and Regeneron Pharmaceuticals Inc. (Nasdaq:REGN), 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.
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Both Amgen and Sanofi have released data suggesting the drugs can reduce major cardiac complications, such as a heart attack or stroke, as well as deaths as they lower bad cholesterol. While the findings weren’t definite and longer-term studies, now under way, are needed to confirm the effect, the positive data may help persuade insurers to cover the drugs, which are known as PCSK9 inhibitors.