Esperion Earns FDA Approval for Cholesterol Lowering Drug Nexletol

February 27, 2020 - Esperion recently announced that the FDA approved Nexletol an LDL-cholesterol lowering medicine, boosting access to medicine for patients with familial hypercholesterolemia or atherosclerotic cardiovascular disease. 

The drug is the first oral, once-daily, non-statin LCL-cholesterol lowering drug approved since 2002 for indicated patients.

“The FDA approved Nexletol provides an important option for patients living with elevated LDL-C and ASCVD or increased risk for cardiovascular disease because of HeFH,” Christie M. Ballantyne, MD, chairman of Esperion’s phase 3 executive committee and professor and chief of cardiology at Baylor College of Medicine in Houston said in the announcement. 

Increased LDL-C contributes to a buildup of bad fat in the arteries which may lead to cardiovascular events such as heart attack and stroke. Only 15 million patients in the US cannot achieve guideline-recommended LDL-C levels despite various care treatments.

“There are millions of patients who are unable to reach their LDL-C targets, despite available medicines,” Ballantyne continued. “NEXLETOL is the first oral, once-fairly, non-statin treatment option for indicated patients in nearly two decades.” 

Nexletol is a first-in-class ATP citrate lyase inhibitor that lowers LDL-cholesterol by inhibiting cholesterol synthesis in the liver.

The drug is designed for individuals who are able to tolerate or failed to see significant effects from statin pills like Lipitor and Crestor. It is expected to be commercially available in the US by prescription only on March 20, 2020. 

“NEXLETOL delivers upon a commitment we’ve made to millions of patients for new treatment alternative if they struggle with bad cholesterol and have ASCVD or HeFH,” Tim Mayleben, president and chief executive officer of Esperion, said in the announcement. 

The FDA made the decision to approve the first oral, once-daily, non-statin LCL-cholesterol lowering drug in decades after Nexletol’s Phase 3 LDL-C lowering program. In the program studies, the drug provided an average of 18 percent placebo corrected LDL-C lowering when used with moderate or high-intensity statins among more than 3,000 patients, the announcement stated. 

Results from these studies have been published in The New England Journal of Medicine and The Journal of the American Medical Association.

The drug earned FDA approval following a shaky start to clinical trials. A study of more than 2,200 patients who were taking Nexletol uncovered several more deaths from the heart problems in the Nexletol group than among those given placebo pills. 

But the announcement stressed that this is likely a random imbalance and nothing to be concerned about. “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.” 

An additional study is currently underway and the results from that study are expected to be released in late 2022.

Esperion will now face new market challenges following the FDA’s approval.

Drug affordability is a continuous issue in healthcare. Although Esperion claimed it is committed to achieving a low-cost, highly effective drug, the previously-planned price for Nexletol was nearly $300 per month. 

But most recent reports showed that eligible patients with commercial drug insurance may pay as little as $10 per fill for a three-month supply. 

The prices of cholesterol-lowering drugs has been a major sticking point for payers, who have been resistant to paying higher costs for the common condition. And this has led to worse patient outcomes.

A recent study published in Circulation: Cardiovascular Quality and Outcomes found that high-risk individuals had a 16 percent increased risk of a cardiovascular event during the 11.5-month study period when their PCSK9is were rejected by their insurance plan. The study also found that individuals who did not fill their prescriptions had an immediate 21 percent increased risk of a cardiovascular event during the study period. The unfilled prescriptions were likely due to higher out-of-pocket costs.

Drug companies manufacturing cholesterol-lowering drugs that are not the typical statin have been forced to slash their prices, including Amgen which recently slashed the price of Repatha by 60 percent following market pressure.

Esperion is taking a page from its competitors and offering Nexletol at a significantly lower price.

“Today’s approval underscores Esperion’s commitment to deliver NEXLETOL to adult patients suffering from ASCVD or HeFH and who are unable to reach their LDL-C goal on maximally tolerated statins. Esperion is working with health insurance providers to help ensure broad insurance coverage and patient access to NEXLETOL,” the company stated.