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ARTICLE | Clinical News

Esperion combo lowers LDL-C in Phase III for high-risk ASCVD

August 31, 2018 6:51 PM UTC

Esperion Therapeutics Inc. (NASDAQ:ESPR) said its bempedoic acid/ezetimibe combination pill met the primary endpoint of reducing LDL-C in the Phase III 1002-053 trial to treat hypercholesterolemia in high-risk atherosclerotic cardiovascular disease (ASCVD) patients on maximally tolerated statins. The company reiterated its plans to submit NDAs to FDA in 1Q19 and MAAs to EMA in 2Q19 for bempedoic acid as monotherapy and as a combination pill with ezetimibe for LDL-C-lowering indications.

Esperion also said it now expects data in October from the fifth and final Phase III trial in its LDL-C lowering program -- Study 1002-047 evaluating bempedoic acid as monotherapy to treat ASCVD in 779 patients on maximally tolerated statins. The company had previously expected that trial's data in September...

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