FDA Approves Nexletol (bempedoic acid) to Lower LDL-Cholesterol

Nexletol (bempedoic acid) is a first-in-class, adenosine triphosphate-citrate lyase (ACL) inhibitor for the treatment of adults with heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease who require additional lowering of LDL-Cholesterol.

INDICATIONS AND USAGE;

 NEXLETOL is an adenosine triphosphate-citrate lyase (ACL) inhibitor 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.

DOSAGE AND ADMINISTRATION

The recommended dosage of NEXLETOL, in combination with maximally tolerated statin therapy, is 180 mg administered orally once daily. NEXLETOL can be taken with or without food. After initiation of NEXLETOL, analyze lipid levels within 8 to 12 weeks.

DOSAGE FORMS AND STRENGTHS;

 NEXLETOL is available as: • Tablets: 180 mg, white to off-white, oval shaped, debossed with “180” on one side and “ESP” on the other side.

WARNINGS AND PRECAUTIONS;

 Hyperuricemia: 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.

Tendon Rupture: 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;

 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

• Simvastatin: Avoid concomitant use of NEXLETOL with simvastatin greater than 20 mg. 
• Pravastatin: Avoid concomitant use of NEXLETOL with pravastatin greater than 40 mg. 

Source;-

1.https://www.drugs.com/history/nexletol.html

2.https://pi.esperion.com/nexletol/nexletol-pi.pdf

3.https://www.esperion.com/product/nexletol

4.https://www.fda.gov/drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products/novel-drug-approvals-2020