28 February 2019 - Esperion today announced that the company has successfully completed important and key global marketing applications including the submission of two new drug applications for bempedoic acid and the bempedoic acid/ezetimibe combination tablet to the U.S. FDA. 

Bempedoic acid and the bempedoic acid / ezetimibe combination tablet are being developed as complementary, cost-effective, convenient, once-daily, oral therapies for the treatment of patients with elevated low-density lipoprotein cholesterol (LDL-C) who need additional LDL-C lowering despite the use of currently accessible therapies. Based on Esperion’s bempedoic acid submission date of February 20, 2019 as well as the bempedoic acid/ezetimibe combination tablet submission date of February 26, 2019, the Company expects to receive notification from FDA on whether the submissions were filed for review in May 2019.

Esperion also announced that the EMA has completed formal validation of Esperion’s two marketing authorisation applications and officially started the review procedure for both bempedoic acid and the bempedoic acid/ezetimibe combination tablet.

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