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U.S. FDA Updates LDL-C Lowering Indication for Esperion’s NEXLETOL® (bempedoic acid) Tablet and NEXLIZET® (bempedoic acid and ezetimibe) Tablet
– Updated Label Adds Primary Hyperlipidemia, Removes Maximally Tolerated Statin Requirement, Removes Limitation of Use – – Cardiovascular (CV) Risk Reduction
About this update from Esperion Therapeutics, Inc.
[{"type":"text","content":"– 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. 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. 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. 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 significantly reduce cardiovascular risk across a range of primary and second endpoints. These applications were accepted by the FDA which issued a PDUFA, or action, date of March 31, 2024. The Company’s EMA applications also remain on track, with anticipated approval in the first half of 2024. INDICATIONNEXLETOL /NEXLIZET is indicated as an adjunct to diet and statin therapy for the treatment of primary hyperlipidemia in adults with heterozygous familial hypercholesterolemia (HeFH) or atherosclerotic cardiovascular disease, who require additional lowering of LDL-C. IMPO...