FDA Approves Merck Daily Pill Lipfendra to Lower LDL Cholesterol

The Food and Drug Administration approved the daily oral pill enlicitide, sold under the brand name Lipfendra, on Thursday. Manufactured by Merck, the drug inhibits the protein PCSK9 and can lower LDL cholesterol to 50 or 60 or lower in clinical trials. Adults not taking cholesterol-lowering drugs typically have LDL levels above 100.

American Heart Association and American College of Cardiology guidelines recommend LDL levels below 70 for people with above-average risk of heart attack or stroke and below 55 for patients at high risk, such as those who have already had a heart attack. Lipfendra’s list price is $315 for a 30-day supply, Merck spokesperson Julia Cunningham said. The drug will be available in a few weeks.

Existing injectable PCSK9 inhibitors carry list prices of $500 to $600 a month or more. Only 1 percent of the 6 million eligible patients currently use them. A 24-week trial of Lipfendra involving 2,912 people showed the drug lowered LDL levels by up to 60 percent with no difference in side effects compared with placebo, Merck reported.

PCSK9 inhibitors have been shown to reduce the risk of heart attacks by 20 percent in high-risk patients. Merck is conducting a study to determine whether Lipfendra reduces heart attacks, strokes, and cardiovascular deaths by 20 percent in high-risk people. Dr.

Dean Li, president of Merck Research Laboratories, said he is confident the pill will achieve that reduction. Primary care doctors can prescribe Lipfendra. Patients are already accustomed to daily pills, Li said.

Dr. Christopher Cannon, a cardiologist at Brigham and Women’s Hospital in Boston, said he is thrilled. Dr. David Maron, a preventive cardiologist at Stanford, said the pill would make a big difference compared with the cost of injectable PCSK9 inhibitors.