(CNN)The US Food and Drug Administration on Friday approved a drug to treat high cholesterol that works differently than statins, according to Esperion Therapeutics, the company that makes the drug.
The FDA approved this drug based on the fact that it can lower cholesterol, but it's still being studied to see if it will lower the risk of stroke and heart attack in patients who can't tolerate statins.
Nexletol works by inhibiting cholesterol production. It can reduce LDL cholesterol by 28% the company said. The company has also applied for FDA approval to use the drug as a combination pill with ezetimibe, another non-statin. In studies, that combination reduced cholesterol between 38% to 44%, the company said. That FDA decision is expected soon.
The drug was generally well-tolerated in clinical studies, the company said, and label warnings and precautions include hyperuricemia, with the development of gout in some patients and an increased risk of tendon rupture or injury. The most common adverse reactions to the drug were upper respiratory infection, muscle spasms, hyperuricemia, back pain, abdominal pain or discomfort, bronchitis, pain in extremity, anemia and elevated liver enzymes.
"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," said Tim Mayleben, president and chief executive officer of Esperion in a release.
Cholesterol is the waxy, fat-like substance found in many foods. Your body needs it to function, but if your body makes too much, it can build up in the wall of your arteries. When arteries narrow, it restricts blood and oxygen from flowing to your heart and causes heart problems or stroke.
"I definitely think it will be another tool that we have to utilize," said Blumenthal, director of Johns Hopkins Ciccarone Center for the Prevention of Cardiovascular Disease.
Blumenthal said he could see doctors using the new drug if a statin doesn't lower cholesterol enough or if the statin isn't tolerated.
"It's always important to remember," Blumenthal said, "good lifestyle habits are the cornerstone of prevention."