Esperion announced 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 qualification for existing approved populations. Additionally, the maximally tolerated qualification for statin use has been removed, and the prior limitation of use stating "the effect of NEXLIZET or NEXLIZET 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 andNEXLIZET.

These labeling modifications do not impact the full pending label approvals for cardiovascular risk reduction indications for NEXLETOL & 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 N EXLIZET, 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 most common adverse reactions in clinical trials of bempedoic acid (a component of NEXLIZET and NEXLIZET) in 2% of patients and greater than placebo, were upper respiratory tract infection, muscle spasms, hyperuricemia, back pain, abdominal pain or discomfort, bronchitis, pain in extremity, anemia, and elevated liver enzymes. Adverse reactions reported in 2% of patients treated with ezetimibe (a component of NEXLETOL) and at an incidence greater than placebo in clinical trials were upper respiratory tract infection, diarrhea, arthralgia, sinusitis, pain in extremity fatigue, and influenza. In clinical trials of NEXLIZET, the most commonly reported adverse reactions (incidence 3% and greater than placebo) observed that not observed in clinical trials of bemp Toledoic acid or ezetimibe, were urinary tract infection, nasopharyngitis, and constipation.

The CLEAR Program includes 5 label-enabling Phase III studies as well as other key Phase IV studies with the potential to reach more than 70 million people with or at risk for CVD based on elevated LDL-C.