The cholesterol-lowering effect of Sanofi and Regeneron Pharmaceuticals Inc.’s Praluent is significant, U.S. regulators said, while questioning whether the companies should have to prove the drugs cut the risk of heart attack and death before they’re used broadly.
High cholesterol is linked to heart disease, the No. 1 killer of Americans, and drugs that lower bad cholesterol are generally assumed to be good for the heart. Yet, Food and Drug Administration staff will ask outside advisers to consider whether, without a proven link between the drugs and lower heart deaths, cutting bad cholesterol levels is enough to approve the drug in certain patients, according to a report released Friday.
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High cholesterol is linked to heart disease, the No. 1 killer of Americans, and drugs that lower bad cholesterol are generally assumed to be good for the heart. Yet, Food and Drug Administration staff will ask outside advisers to consider whether, without a proven link between the drugs and lower heart deaths, cutting bad cholesterol levels is enough to approve the drug in certain patients, according to a report released Friday.
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