CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 211617Orig1s000 INTEGRATED REVIEW Executive Summary Interdisciplinary Assessment Appendices NDA211617 Nexlizet I bempedoic acid and ezetimibe Integrated Review Table 1. Administrative Application Information Category Application Information Application type NDA Application number 211617 Priority or standard Standard Submit date 2/26/2019 Received date 2/26/2019 PDUFA goal date 2/26/2020 Division/office Division of Metabolism and Endoc1inology Products (DMEP) Review completion date 2/25/2020 Established name Bempedoic acid and ezetimibe (Proposed) trade name Nexlizet Phannacologic class an adenosine triphosphate-citrate lyase (ACL) inhibitor and a cholesterol abso1ption inhibitor Code name ETC-I 002/ezetimibe Applicant Esperion Therapeutics, Inc. Dose form/formulation Tablets, 180 mg/10 mg One tablet dail Applicant proposed Adjunct to diet indication(s)/population(s) Proposed SNOMED 55822004 (hyperlipidemia) indication Regulatory action Approval Approved adjunct to diet and maximally tolerated stat.in therapy for the indication(s)/population(s) treatment of adults with heterozygous familial (if applicable) hypercholesterolemia or established atherosclerotic cardiovascular disease who require additional lowering of LDL-C Approved SNOMED 55822004 (hyperlipidemia) indication Integrated Review Template, version date 2019/06/14 Reference ID 4566970 1'$ 1H[OL]HW EHPSHGRLF DFLG DQG H]HWLPLEH 7DEOH RI &RQWHQWV 7DEOH RI 7DEOHV Y 7DEOH RI )LJXUHV YLLL *ORVVDU\ , ([HFXWLYH 6XPPDU\ 6XPPDU\ RI 5HJXODWRU\ $FWLRQ %HQHILW5LVN $VVHVVPHQW ,, ,QWHUGLVFLSOLQDU\ $VVHVVPHQW ,QWURGXFWLRQ $SSURDFK WR WKH 5HYLHZ 3DWLHQW ([SHULHQFH 'DWD 3KDUPDFRORJLF $FWLYLW\ 3KDUPDFRNLQHWLFV DQG &OLQLFDO 3KDUPDFRORJ\ 1RQFOLQLFDO $VVHVVPHQW RI 3RWHQWLDO (IIHFWLYHQHVV 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