Just days after it received approval for its non-statin drug for lowering cholesterol, Esperion Therapeutics has won approval for its second product.
The Food and Drug Administration on Wednesday approved the Ann Arbor, Michigan-based company’s Nexlizet (bempedoic acid, ezetimibe), following the approval last Friday of Nexletol, according to a new entry in the FDA’s database of approved drugs. Nexlizet combines the active ingredient of Nexletol with ezetimibe, a non-statin drug for cholesterol that is available as a generic.
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Like Nexletol, Nexlizet is approved as an adjunct to diet and as much of a statin drug as patients can tolerate for treating high LDL cholesterol in patients with heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease.
Shares of Esperion were up 2.6% in after-hours trading on the Nasdaq Wednesday following the approval.
The approval is based on data from a Phase III trial that randomized patients to receive Nexlizet, Nexletol, ezetimibe alone or placebo as a daily add-on to baseline statin therapy, according to the drug’s label. The difference between patients on Nexlizet and those on placebo was a 38% reduction in LDL cholesterol. In addition, patients on Nexlizet saw greater reductions in LDL cholesterol than those on Nexletol and ezetimibe, while those on placebo saw a slight increase.
While statins generally have benign side-effect profiles, some patients are unable to tolerate them, particularly high-intensity statins like atorvastatin and rosuvastatin, due to relatively rare side effects like muscle pain and new-onset diabetes. Nexletol is an ATP citrate lyase inhibitor that is designed to lower LDL cholesterol through inhibition of cholesterol synthesis in the liver.
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In a conference call with investment bank analysts Monday to announce Nexletol’s approval, executives from the company said that Nexletol would carry a list price of $10 for payers, but that a patient assistance program would price at as low as $10 for a three-month supply for patients. The company plans to monitor for abandonment of prescriptions, which executives noted is often due to patient concerns about high drug prices.
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