The Food and Drug Administration approved Lipfendra, also known as enlicitide, for adults with high cholesterol, including people with heterozygous familial hypercholesterolemia. The once-daily tablet is intended to be used alongside diet and exercise.

The medicine is the first oral treatment approved in the United States to inhibit PCSK9, a protein involved in regulating LDL cholesterol. Other approved PCSK9 inhibitors have generally been given by injection.

The FDA based its decision on two randomized, placebo-controlled trials involving 3,207 adults who were already receiving the maximum statin treatment they could tolerate. At 24 weeks, average LDL levels were 56 percent lower in one Lipfendra group and 59 percent lower in the trial limited to adults with inherited high cholesterol, compared with placebo.

The approval establishes that the drug lowers LDL; it should not be read as proof from these trials alone that it reduces heart attacks or strokes. In the inherited-cholesterol trial, diarrhea and dizziness were the most common reactions occurring more often than with placebo. Treatment decisions should be made with a clinician who can assess an individual patient's risks and current medicines.

Source: U.S. Food and Drug Administration ↗

Source: Associated Press ↗