The U.S. Food and Drug Administration (FDA) approved Ann Arbor, Michigan-based Esperion’s Nexlizet (bempedoic acid and ezetimibe) for lowering LDL-Cholesterol (LDL-C). The drug is an oral, once-daily, non-statin indicated with diet and maximally tolerated statins for adults with heterozygous familial hypercholesterolemia (HeFH) or established atherosclerotic cardiovascular disease (ASCVD) who need additional help lowering LDL-C.
Last week, the agency approved Nexletol (bempedoic acid) for the same indications.
“The approval of Nexlizet underscores Esperion’s commitment to providing patients and their healthcare providers with innovative non-statin medicines that fit into their everyday routines to lower elevated levels of bad cholesterol in adult patients with ASCVD or HeFH on maximally tolerated statins,” said Tim M. Mayleben, president and chief executive officer of Esperion. “This is the first non-statin combination medicine ever approved for lowering LDL-C. We are truly grateful to all the patients and healthcare providers who put their confidence in Esperion’s team of lipid experts”
Nexlizet’s approval was supported by the Phase III Fixed Combination Drug Product LDL-C Lowering program in addition to safety data from the Nexletol tablet global pivotal Phase III LDL-C lowering program and the existing safety profile of ezetimibe. In the trials, Nexlizet decreased LDL-C by a mean of 38% compared to placebo when added to the maximum tolerated dose of statins.
The drug was generally well-tolerated. There are warnings and precautions about hyperuricemia and the possible development of gout as well as increased risk of tendon rupture or injury. The most common adverse events, which were about the same as in the placebo group, were upper respiratory tract infection, muscle spasms, hyperuricemia, back pain, abdominal pain or discomfort, bronchitis, pain in the extremities, anemia, elevated liver enzymes, diarrhea, arthralgia, sinusitis fatigue, and influenza.
Nexlizet is expected to be on the market in the U.S. in July 2020. Nexletol will be marketed in the U.S. on March 30, 2020. Both are prescription only.
The company indicates plans to price the drugs “at parity,” and suggest that some patients with commercial drug insurance plans may pay as little as $10 per fill-up to a three-month supply.
“Nexlizet provides significant additional LDL-C lowering for adult patients with ASCVD or HeFH when added to maximally tolerated statin medicine, including those patients for whom maximally tolerated statin may be no statin at all,” said Christie M. Ballantyne, chairman of Esperion’s Phase III Executive Committee and professor and chief of cardiology at Baylor College of Medicine in Houston. “I believe this one-of-a-kind combination medicine which has two complementary, non-statin medications can provide highly effective additional reductions in LDL-C when added to statin therapy. It also has the conventional, oral, once-daily administration which can prove beneficial to patients struggling to meet their cholesterol goals with the currently available statin options in their daily regimen.”
About 40 million people in the U.S. take statins to lower their cholesterol. Esperion’s drugs are targeted at the approximately 8.5 million people who take statins whose cholesterol doesn’t decrease to the desired levels. The company will also target another 9.5 million patients who can’t take statins for a variety of reasons. It is estimated that in the U.S. about 100 million people have one type of high cholesterol.
