– Updated Label Adds Primary Hyperlipidemia, Removes Maximally Tolerated Statin Requirement, Removes Limitation of Use – – Cardiovascular (CV) Risk Reduction Labels Remain on Track: in U.S. with PDUFA Date of March 31; in Europe with Anticipated Approval in 1H 2024 – ANN ARBOR, Mich., Dec. 13, 2023 (GLOBE NEWSWIRE) -- Esperion (NASDAQ: ESPR) announced today that the U.S.

–更新标签增加了原发性高脂血症，删除了最大耐受性他汀类药物的要求，删除了使用限制–心血管（CV）风险降低标签仍在轨道上：在美国，PDUFA日期为3月31日；在欧洲，预计将于2024年上半年获得批准——密歇根州安娜堡，2023年12月13日（环球通讯社）——Esperion（纳斯达克：ESPR）今天宣布，美国。

Food and Drug Administration (FDA) has approved an updated LDL-cholesterol lowering indication for NEXLETOL and NEXLIZET to include the treatment of primary hyperlipidemia as a qualifier for existing approved populations. Additionally, the maximally tolerated qualifier for statin use has been removed, and the prior limitation of use stating “the effect of NEXLIZET or NEXLETOL on cardiovascular morbidity and mortality has not been determined” has also been removed.

美国食品和药物管理局（FDA）已批准NEXLETOL和NEXLIZET的最新低密度脂蛋白胆固醇降低适应症，将原发性高脂血症的治疗作为现有批准人群的限定条件。此外，他汀类药物使用的最大耐受性限定词已被删除，并且先前的使用限制也已删除，该限制声明“NEXLIZET或NEXLETOL对心血管疾病发病率和死亡率的影响尚未确定”。

This update is effective immediately and is the result of the FDA’s efforts to modernize and synchronize drug labels, as well as Esperion’s commitment to expanding the indications for NEXLETOL and NEXLIZET. “We are pleased that the FDA has approved these modifications to our current indications for NEXLETOL and NEXLIZET, which reinforce the proven efficacy and safety of these treatments,” said Sheldon Koenig, President and CEO.

这一更新立即生效，是FDA努力使药物标签现代化和同步化的结果，也是Esperion致力于扩大NEXLETOL和NEXLIZET适应症的结果。总裁兼首席执行官谢尔顿·柯尼格（SheldonKoenig）说：“我们很高兴FDA批准了对我们目前用于奈克索和奈克丽泽的适应症的这些修改，这加强了这些治疗的有效性和安全性。”。

These labeling modifications do not impact the full pending label approvals for cardiovascular risk reduction indications for NEXLETOL and NEXLIZET, which remain on track for anticipated approval in the first quarter of 2024. In June 2023, the Company announced its submission of four Supplemental New Drug Applications based on the landmark Cholesterol Lowering via Bempedoic acid, an ACL-Inhibiting Regimen (CLEAR) Outcomes trial, which demonstrated that bempedoic acid, contained in both NEXLETOL and NEXLIZET, can sign.

这些标签修改不会影响NEXLETOL和NEXLIZET心血管风险降低适应症的全部待定标签批准，预计将于2024年第一季度获得批准。2023年6月，该公司宣布提交了四份补充新药申请，该申请基于具有里程碑意义的通过苯丙二酸降低胆固醇，这是一项ACL抑制方案（CLEAR）结果试验，该试验证明了NEXLETOL和NEXLIZET中都含有苯丙二酸，可以签署。