(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.
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.
Sanofi said in January that the EMA had accepted its application. The agency hasn’t yet issued a recommendation on Sanofi’s drug.
The agency’s recommendations are the final stage before the European Commission, the EU’s executive arm, approves or rejects a drug for sale to patients in the 28-nation region.
--With assistance from Makiko Kitamura and Oliver Staley in London and Simeon Bennett in Geneva.
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