science
FDA approves oral cholesterol drug for high-risk patients
The Food and Drug Administration approved a new pill from Merck that lowers LDL cholesterol in patients whose levels remain elevated after statin use. The medication blocks a liver protein previously targeted only by injectable drugs.
Jul 20, 1:14 PM·1m read1 source
Los Angeles TimesAudio version
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The Food and Drug Administration approved a pill that lowers LDL cholesterol in high-risk patients whose levels stay elevated after statin treatment. The drug blocks a liver protein called PCSK9 and is the first non-injectable medication to target that protein.
Merck will market the pill under the brand name Lipfendra. It received approval based on two studies involving high-risk patients who added the pill to their existing statin regimens.
In one study of 3,000 patients, LDL cholesterol fell more than 55 percent after six months. A second study showed an average reduction of 59 percent compared with a placebo group. The benefit remained largely stable over a year, and side effects such as dizziness and diarrhea occurred at similar rates in both groups.
The pill must be taken on an empty stomach. The FDA reviewed the drug through its accelerated pathway for medications serving the public interest.
Statins remain the standard treatment for lowering cholesterol and reducing heart-attack risk. Many patients still require additional medication to reach recommended LDL targets. Heart disease is the leading cause of death in the United States, and elevated LDL cholesterol is a major contributing factor.
