Simulation Model based on Pooled Phase 3 Data Demonstrating NEXLETOL (bempedoic acid) Tablet’s Potential to Lower Absolute Cardiovascular Event Risk Presented at ACC.21 - Seite 3

The impact of NEXLETOL on cardiovascular morbidity and mortality has not been determined is currently being investigated as part of the ongoing CLEAR Outcomes study in more than 14,000 statin-intolerant patients with or at high risk for ASCVD.⁹

The 2020 approval of NEXLETOL in the U.S. was supported by a global pivotal Phase 3 LDL-C-lowering program conducted in more than 3,000 patients with ASCVD and/or heterozygous familial hypercholesterolemia (HeFH) on maximally tolerated statins. In these studies, NEXLETOL provided an average of 18% placebo-corrected LDL-C lowering at week 12 when used with moderate or high-intensity statins. The most common (incidence ≥2% and greater than placebo) adverse reactions were upper respiratory tract infection, muscle spasms, hyperuricemia, back pain, abdominal pain or discomfort, bronchitis, pain in extremity, anemia and elevated liver enzymes. NEXLETOL is indicated as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with HeFH or established ASCVD who require additional lowering of LDL-C. Please see important safety information below.

NEXLETOL^ (bempedoic acid) Tablet

NEXLETOL is a first-in-class ATP Citrate Lyase (ACL) inhibitor that lowers LDL-C by reducing cholesterol biosynthesis and up-regulating the LDL receptors. NEXLETOL is the first oral, once-daily, non-statin LDL-C lowering medicine approved in the U.S. in nearly 20 years for patients with ASCVD or HeFH. NEXLETOL was approved by the FDA in February 2020, and by the European Commission in April 2020 under the name NILEMDO (bempedoic acid) with a different label.¹⁰ Daiichi Sankyo Europe has licensed exclusive commercialization rights to bempedoic acid in the European Economic Area, Switzerland and Turkey from Esperion, and is the full marketing authorization holder in these territories.

Indication and Limitation of Use

NEXLETOL is indicated as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease who require additional lowering of LDL-C. The effect of NEXLETOL on cardiovascular morbidity and mortality has not been determined.

Important Safety Information

• Warnings and Precautions:
  • Elevations in serum uric acid have occurred. Assess uric acid levels periodically as clinically indicated. Monitor for signs and symptoms of hyperuricemia, and initiate treatment with urate-lowering drugs as appropriate. The risk for gout events with NEXLETOL was higher in patients with a prior history of gout although gout also occurred more frequently than placebo in patients treated with NEXLETOL who had no prior gout history.
  • Tendon rupture has occurred. Discontinue NEXLETOL at the first sign of tendon rupture. Avoid NEXLETOL in patients who have a history of tendon disorders or tendon rupture.
• Adverse Reactions:
  • The most common (incidence ≥ 2% and greater than placebo) adverse reactions are upper respiratory tract infection, muscle spasms, hyperuricemia, back pain, abdominal pain or discomfort, bronchitis, pain in extremity, anemia and elevated liver enzymes.
• Drug Interactions:
  • Avoid concomitant use of NEXLETOL with simvastatin greater than 20 mg.
  • Avoid concomitant use of NEXLETOL with pravastatin greater than 40 mg.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088 or report side effects to Esperion at 833-377-7633 (833 ESPRMED).