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Discontinue NEXLIZET at the first sign of tendon rupture. Consider alternative therapy in patients who have a history of tendon disorders or tendon rupture. - The most common adverse reactions in the primary hyperlipidemia trials of bempedoic acid (a component of 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 NEXLIZET) 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 the primary hyperlipidemia trials of NEXLIZET, the most commonly reported adverse reactions (incidence 3% and greater than placebo) observed with NEXLIZET, but not observed in clinical trials of bempedoic acid or ezetimibe, were urinary tract infection, nasopharyngitis, and constipation. - The most common adverse reactions in the cardiovascular outcomes trial of bempedoic acid (a component of NEXLIZET) at an incidence of 2% and 0.5% greater than placebo were hyperuricemia, renal impairment, anemia, elevated liver enzymes, muscle spasms, gout, and cholelithiasis. - Discontinue NEXLIZET when pregnancy is recognized unless the benefits of therapy outweigh the potential risks to the fetus.
Assess uric acid levels periodically as clinically indicated. Monitor for signs and symptoms of hyperuricemia, and initiate treatment with urate-lowering drugs as appropriate. - Tendon Rupture: Bempedoic acid, a component of NEXLIZET, is associated with an increased risk of tendon rupture or injury. Tendon rupture may occur more frequently in patients over 60 years of age, in those taking corticosteroid or fluoroquinolone drugs, in patients with renal failure, and in patients with previous tendon disorders.
Serious hypersensitivity reactions, such as anaphylaxis, angioedema, rash, and urticaria have been reported with ezetimibe or bempedoic acid. - Hyperuricemia: Bempedoic acid, a component of NEXLIZET, may increase blood uric acid levels, which may lead to gout. Hyperuricemia may occur early in treatment and persist throughout treatment, returning to baseline following discontinuation of treatment.
Because of the potential for serious adverse reactions in a breast-fed infant, breastfeeding is not recommended during treatment with NEXLETOL. - Report pregnancies to Esperion Therapeutics, Inc. Adverse Event reporting line at 1-833-377-7633. See full prescribing information here. NEXLIZET (bempedoic acid and ezetimibe) Important Safety Information 26 2025 Esperion Therapeutics, Inc.
Discontinue NEXLETOL at the first sign of tendon rupture. Consider alternative therapy in patients who have a history of tendon disorders or tendon rupture. - The most common adverse reactions in the primary hyperlipidemia trials of NEXLETOL 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. - The most common adverse reactions in the cardiovascular outcomes trial for NEXLETOL at an incidence of 2% and 0.5% greater than placebo were hyperuricemia, renal impairment, anemia, elevated liver enzymes, muscle spasms, gout, and cholelithiasis. - Discontinue NEXLETOL when pregnancy is recognized unless the benefits of therapy outweigh the potential risks to the fetus.
Monitor for signs and symptoms of hyperuricemia, and initiate treatment with urate-lowering drugs as appropriate. - Tendon Rupture: NEXLETOL is associated with an increased risk of tendon rupture or injury. Tendon rupture may occur more frequently in patients over 60 years of age, in those taking corticosteroid or fluoroquinolone drugs, in patients with renal failure, and in patients with previous tendon disorders.
Serious hypersensitivity reactions, such as angioedema, have occurred. - Hyperuricemia: NEXLETOL may increase blood uric acid levels, which may lead to gout. Hyperuricemia may occur early in treatment and persist throughout treatment, returning to baseline following discontinuation of treatment. Assess uric acid levels periodically as clinically indicated.
Nexletol (bempedoic acid) Tablets [Package Insert]. Ann Arbor, MI: Esperion Therapeutics, Inc.; 2. J Am Coll Cardiol. 2023 Apr 25;81(16):1553-1564. Esperion has not conducted any head-to-head studies comparing its product candidates to any third party drug products or candidates, whether investigated or approved. Information regarding other drug products in this presentation is meant to provide context for illustrative purposes only.
Proceedings of the National Academy of Sciences of the United States of America. 2010;107:7401 6 Esperion has not conducted any head-to-head studies comparing its product candidates to any third party drug products or candidates, whether investigated or approved. Information regarding other drug products in this presentation is meant to provide context for illustrative purposes only.
Nexletol (bempedoic acid) Tablets [Package Insert]; Nexlizet (bempedoic acid and ezetimibe) [Package Insert] Ann Arbor, MI: Esperion Therapeutics, Inc.; 2. New Amsterdam Pharma Conference Call Presentation December 10, 2024. 3. N Engl J Med. 2007;357:2109 22; 4. N Engl J Med. 2012;367:2089 99; 5. N Engl J Med. 2017;376:1933 1942; 6. N Engl J Med. 2017;377:1217 1227.; 7.
Liang H, et al. Medicine (Baltimore). 2017;96(24):e7116.; 4. Boonstra K, et al. Hepatology. 2013;58(6):2045-55.; 5. Krampe, J, et al. Poster presented at: ISPOR 2024; Nov 2, 2024; Barcelona, Spain Annual Market Opportunity Estimate - No approved therapies with proven efficacy to cure or halt PSC progression - High healthcare burden from hospitalization, transplants, and long-term management costs - Death or liver transplantation expected within 1- 2 decades after diagnosis - Potential Orphan Drug Designation & Fast Track Approval - Discovery program is internally developed and wholly-owned globally PSC: A Rare and Progressive Liver Disease 30K3-5 >$1B 46K1-2 ~76K PSC: primary sclerosing cholangitis Development Timeline 2025 2026 Early 2030's Pre-IND Interactions with FDA Pre-Clinical IND-Enabling Studies IND Filing Phase 1 Clinical Studies Commercialization / Market Launch FDA: Food and Drug Administration IND Enabling Clinical Development Registration/Launch Candidate Nomination Discovery 19 2025 Esperion Therapeutics, Inc.
USPI for Repatha (Nov 2024), Praluent (March 2024) and Leqvio (July 2024) No head-to-head studies have been conducted; cross-study data reflect different study designs, populations, and other features. Approval Status LDL-C reduction Administration Dosing In development ~ 60% - 70% Once daily Triple Combo1 Approved/Generic 19% Once daily In development 33% Once daily 3 approved products ~ 48% - 71% Bi-weekly to 6 months Ezetimibe2 Obicetrapib3 PCSK9i4 Oral CETP inhibitor not approved with unknown safety profile.
Variations within the specific wording of each product indication. No head-to-head studies have been conducted; cross-study data reflect different study designs, populations, and other features. The Next Step in Cardiovascular Risk Reduction 12 CV Risk Reduction 27% Nonfatal MI Coronary Revascularization 19% CLEAR Outcomes Primary Prevention* 32% MACE-4 (nonfatal MI, coronary revascularization, nonfatal stroke, or CV death) LDL-C Reduction 38% Not activated in skeletal muscle Does not raise glucose Reduces hsCRP Use with or without a statin HR, 0.73 (95% CI: 0.62-0.87) HR, 0.81 (95% CI: 0.72-0.92) HR, 0.68 (95% CI: 0.53-0.87) The primary endpoint was percent change from baseline to Week 12 in LDL-C.
The choice should be based on the magnitude of additional LDL-C lowering needed. I A Bempedoic acid is recommended in patients who are unable to take statin therapy to achieve the LDL-C goal. I B The addition of bempedoic acid to the maximally tolerated dose of statin with or without ezetimibe should be considered in patients at high or very high risk in order to achieve the LDL-C goal.
Allen JM, et al. Circulation. 2019;140:A12904. 2. Shen M, Nargesi AA, et al. J Am Heart Assoc. 2022;11:e026075. 3. Yang Y, et al. Circulation. 2021;144:A10434. 4. Wong ND, et al. J Clin Lipidology. 2016;10:1109-1118. 5. Bytyci I, et al. Eur Heart J. 2022;00:1-16. 6. Total U.S. Resident Population by Age, Sex, and Series: April 1, 2020 [table]; US Census Bureau: 2020. 7.
Metser G. et al. Am J Cardiol. 2021;161:36-41 . 3.Allen JM, et al. Circulation. 2019;140:A12904. 4. Yang Y, et al. Circulation. 2021;144:A10434. 5. Wong ND, et al. J Clin Lipid.2016;10:1109-1118. 6. Cheeley MK, et al. J Clin Lipidol. 2022 Jul-Aug;16(4):361-375. 7. Ahmad FB, Anderson RN. JAMA. 2021;325(18):1829- 1830. 8. Tsao C, et al. Circulation. 2023;147:e93-e621. 9.
Information re garding othe r drug produc ts in this pre s e ntation is me ant to provide c onte xt for illus trative purpos e s only. Be c aus e the re are no head-to-he ad s tudie s , no c onc lus ions s hould be made bas e d on c ros s s tudy c omparis ons . Re c ipie nts are c autione d not to plac e undue re lianc e on the s e forward looking s tate me nts , whic h s pe ak only as of the date s uc h s tate me nts are made and s hould not be c ons true d as statements of fact.
In addition, no inde pe nde nt s ourc e has e valuate d the re as onable ne s s or ac c urac y of Es pe rion's inte rnal e s timate s or re s e arc h and no re lianc e s hould be made on any information or s tate me nts made in this pre s e ntation re lating to or bas e d on s uc h inte rnal e s timate s and re s e arc h. Finally, Es pe rion has not c onduc te d any he ad-to-he ad s tudie s c omparing its produc t c andidate s to any third party drug produc ts or c andidate s , whe the r inve s tigate d or approve d.
Ce rtain information c ontaine d in this pre s e ntation re late s to or is bas e d on s tudie s , public ations , s urve ys and othe r data obtaine d from third-party s ourc e s and Es pe rion's own inte rnal e s timate s and re s e arc h. While Es pe rion be lie ve s the s e third-party s tudie s , public ations , s urve ys and othe r data to be re liable as of the date of this pre s e ntation, Es pe rion has not inde pe nde ntly ve rifie d, and make no re pre s e ntation as to the ade quac y, fairne s s , ac c urac y or c omple te ne s s of, any information obtaine d from third-party s ourc e s .
Any forward-looking s tate me nts c ontaine d in this pre s e ntation s pe ak only as of the date he re of, and Es pe rion dis c laims any obligation or unde rtaking to update or re vis e any forward-looking s tate me nts c ontaine d in this pre s e ntation, othe r than to the e xte nt re quire d by law. No re pre s e ntations or warrantie s (e xpre s s e d or implie d) are made about the ac c urac y of any s uc h forward-looking s tate me nts .
Any e xpre s s or implie d s tate me nts c ontaine d in this pre s e ntation that are not s tate me nts of his toric al fac t may be de e me d to be forward-looking s tate me nts. Forward-looking s tate me nts involve ris ks and unc e rtaintie s that c ould c aus e Es pe rion's ac tual re s ults to diffe r s ignific antly from thos e proje c te d, inc luding, without limitation, the ne t s ale s , profitability, and growth of Es pe rion's c omme rc ial produc ts , c linic al ac tivitie s and re s ults , s upply c hain, c omme rc ial de ve lopme nt and launc h plans , the outc ome s and antic ipate d be ne fits of le gal proc e e dings and s e ttle me nts , and the ris ks de taile d in Es pe rion's filings with the Se c uritie s and Exc hange Commis s ion (the SEC ), inc luding in Es pe rion's mos t re c e nt Annual Re port on Form 10-K and in any s ubs e que nt filings with the SEC.
Because of the potential for serious adverse reactions in a breast-fed infant, breastfeeding is not recommended during treatment with NEXLIZET. - Report pregnancies to Esperion Therapeutics, Inc. Adverse Event reporting line at 1-833-377-7633. See full prescribing information here.