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Inclisiran is approved by both the FDA and EMA for the treatment of hypercholesterolemia, including in adults with primary hypercholesterolemia and heterozygous familial hypercholesterolemia. In the United States, the FDA approved Inclisiran initially in 2021 as an adjunct to diet and maximally tolerated statin therapy to reduce LDL cholesterol levels in adults with hypercholesterolemia. The EMA granted its first approval in December 2020 for a similar indication
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