FDA updates LDL-C lowering indication for Nexletol (bempedoic acid) tablet and Nexlizet (bempedoic acid and ezetimibe) tablet.- Esperion.

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.