What is the new FDA-approved pill designed to slash cholesterol levels?
Adelaide Taylor
Updated:
This November 2020 photo provided by McMaster University shows 75mg aspirin pills, left, and Polycaps, pills from India-based Cadila Pharmaceuticals that contains one cholesterol and three blood pressure medicines, used in the International Polycap Study 3 (TIPS-3). On Friday, Nov. 13, 2020, researchers say the cheap, daily pill taken with low-dose aspirin can cut the risk of heart attacks, strokes and heart-related deaths by nearly one third. (Georgia Kirkos/McMaster University via AP)
(NewsNation) — The Food and Drug Administration approved a daily pill Thursday called Lipfendra, which is designed to send cholesterol levels plummeting.
Made by the pharmaceutical company Merck, Lipfendra is a daily pill containing enlicitide that works by inhibiting a protein known as PCSK9. Clinical trials have shown that Lipfendra can lower LDL, the bad type of cholesterol, by 60%, compared with around 30-50% for most statins.
This type of cholesterol-lowering medication has only been available as injections until Merck’s pill is released in a couple of weeks. The pill format is said to be a convenient and cheaper option for people who don’t want an injection.
Who should take Lipfendra?
Adults not on any cholesterol-lowering drugs usually have levels above 100. According to guidelines issued by the American Heart Association and the American College of Cardiology, people with above-average risk of heart attacks or strokes should get their LDL levels below 70. Those at high risk should get their LDL below 55.
High-risk patients whose cholesterol won’t come down enough with a statin alone could benefit from Lipfendra’s results. In the studies of the injectable drugs, blocking PCSK9 reduced the incidence of heart attacks, strokes and cardiovascular deaths by 20% in high-risk people.
According to The New York Times, Merck is currently conducting a study to see if Lipfendra has the same effect, which they are confident it will.
Additionally, some patients do not respond well to statins, which can cause muscle pain, weakness and headaches as well as gastrointestinal issues. Clinical trials of Lipfendra saw no difference in side effects between the drug and a placebo, according to The New York Times.
However, one consideration is that the pill, which is a peptide drug, must be taken in the morning, 30 minutes before eating, according to The Washington Post.
How much will Lipfendra cost?
Lipfendra’s list price will be $315 for a 30-day supply, Merck spokeswoman Julie Cunningham told The New York Times. Patients with insurance may pay less.
As to how it compares to similar product prices, injectable drugs that work the same way currently cost $500 to $600 a month.
“This is a game changer,” said Erin Michos, a cardiologist and professor at the Johns Hopkins School of Medicine, to The Washington Post. “I have a number of patients who are anxiously waiting for the oral one. They didn’t want to go on an injection. I have to give them a call and say it’s out now.”