Controlling Cholesterol: FDA approves Nexletol- FIRST once daily, non-statin treatment for familial hypercholesterolemia

The FDA approval of NEXLETOL provides an important option for patients living with elevated LDL-C and ASCVD or increased risk for cardiovascular disease because of HeFH," said Christie M. Ballantyne, M.D., chairman of Esperion's Phase 3 Executive Committee and professor and chief of cardiology at Baylor College of Medicine in Houston. "There are millions of patients who are unable to reach their LDL-C targets despite available medicines. NEXLETOL is the first oral, once-daily, non-statin treatment option for indicated patients in nearly two decades."

NEXLETOL was generally well-tolerated in clinical studies. Label warnings and precautions include hyperuricemia, with the development of gout in a small percentage of patients, as well as increased risk of tendon rupture or injury. Overall in Phase 3 studies, the adverse events reported most frequently in patients who received NEXLETOL were generally reported at similar rates in patients who received placebo.

The most common adverse events reported with NEXLETOL (incidence ≥ 2% and greater than placebo) were upper respiratory tract infections, muscle spasms, hyperuricemia, back pain, abdominal pain or discomfort, bronchitis, pain in extremity, anemia, and elevated liver enzymes. The majority of adverse events reported with NEXLETOL were mild to moderate in severity and balanced in occurrence with adverse events in patients receiving placebo.