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

The medicine, called Repatha, was endorsed by a EuropeanMedicines Agency panel as a treatment for patients with highcholesterol that can’t be controlled by statins alone, or who can’ttake statins, the regulator said Friday in a statement. The drughasn’t been approved yet by the U.S. Food and DrugAdministration.

Amgen, based in Thousand Oaks, California, will be competingwith Sanofi and Regeneron Pharmaceuticals Inc., which haveco-developed a similar drug. Amgen has said the potential patientpopulation for Repatha exceeds 25 million, and analysts expect theinjections to generate blockbuster sales.

Both Amgen and Sanofi have released data suggesting the drugscan reduce major cardiac complications, such as a heart attackor stroke, as well as deaths as they lower bad cholesterol. Whilethe findings weren’t definite and longer-term studies, now underway, are needed to confirm the effect, the positive data may helppersuade insurers to cover the drugs, which areknown as PCSK9 inhibitors.

Sanofi said in January that the EMA had accepted itsapplication. The agency hasn’t yet issued a recommendation onSanofi’s drug.

The agency’s recommendations are the final stage before theEuropean Commission, the EU’s executive arm, approves or rejects adrug for sale to patients in the 28-nation region.

--With assistance from Makiko Kitamura and Oliver Staley inLondon and Simeon Bennett in Geneva.

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