The US Food and Drug Administration (FDA) has approved a new drug that lowers cholesterol levels.The drug, known as Nexletol, works differently from existing treatments known as statins (such as Lipitor and Crestor) meaning that for those who don’t respond well to more conventional drugs, this new drug may become a frontline treatment.
Made from a combination of bempedoic acid and ezetimibe, Nexletol works by inhibiting ATP Citrate Lyase and thus lowering Low Density Lipoprotein Cholesterol (LDL-C) by blocking the synthesis of cholesterol in the liver. To be taken as a pill per day and to work alongside a healthy diet, Tim Mayleben, the president of Esperion, the pharmaceutical company behind Nexletol, said, “Even with maximally tolerated statins, which may mean no statin at all, some of these patients can’t achieve their LDL-C goals. Today’s approval provides them with a new medicine to go along with a healthy diet.”
The approval of the drug by the FDA comes after the results of a Phase III LDL-C lowering program that included over 3,000 patients worldwide. When delivered in parallel with a placebo, researchers found that it could lower LDL levels by 25%, and when taken with a statin: 18%.
However, in studies funded by Esperion, researchers also found that Nexletol has side effects including high blood pressure, muscle pain and joint pain, with tendon rupture and respiratory tract infections alongside elevated liver enzymes and hyperuricemia having also occurred. Furthermore, in another study comprising over 2,200 patients, researchers found that people were more likely to die from heart problems when taking Nexletol than those on placebo treatments. According to co-director of Duke Heart Center however, this result was likely just a random imbalance, and thus nothing of significant concern.
To be available on the market for roughly $10 per day, Esperion now has a study underway to assess whether the drug may lower one’s overall risk for having a heart attack alongside other cardiovascular problems beyond cholesterol. While results from this study are expected to surface in late 2022, the company estimates that Nexletol may be able to help up to 18 million Americans in the meantime, as well as over 100 million people in other countries.