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ARTICLE | Company News

Esperion submits NDAs to FDA for LDL-C lowering products, EMA starts review

March 8, 2019 5:36 PM UTC

Esperion said it submitted two NDAs to FDA for bempedoic acid (ETC-1002) and a bempedoic acid/ezetimibe combination tablet to treat elevated LDL-C in patients who need additional LDL-C lowering despite the use of currently accessible therapies.

Esperion Therapeutics Inc. (NASDAQ:ESPR) also said EMA validated MAAs for the products. Daiichi Sankyo Co. Ltd. (Tokyo:4568) exclusive rights to commercialize both bempedoic products in the European Economic Area and Switzerland...