FDA approves a first-of-its-kind pill to cut cholesterol in high-risk
patients
[July 17, 2026]
By MATTHEW PERRONE
WASHINGTON (AP) — The Food and Drug Administration has approved a
first-of-its-kind pill that can drastically reduce cholesterol in a way
that's previously only been available with expensive, injectable drugs.
The drug from Merck was OK'd on Thursday for patients with
artery-clogging cholesterol that persists even after taking statins, the
standard medications for cutting heart attack risk. Merck will market
its pill under the brand name Lipfendra.
It's the first noninjectable medication that works by blocking a liver
protein called PCSK9. That protein limits the body's ability to clear
cholesterol from the blood, and biotech injectables targeting it have
been available from Amgen and other drugmakers for more than a decade.
But patient access has been stymied for years by high prices, insurance
restrictions and limited prescribing by doctors.
Statins block some of the liver’s production of cholesterol and are the
cornerstone of treatment. But even at the highest doses, many people
need additional help lowering their LDL, or bad, cholesterol enough to
meet medical guidelines.
Merck, which has headquarters in Rahway, New Jersey, won approval based
on two studies in high-risk patients who added the company's pill to
their standard treatment, including statins. In one study of 3,000
patients, those taking Lipfendra saw their levels of LDL cholesterol
drop more than 55% after six months. In a second study, patients
averaged a reduction of 59% compared with patients who received a dummy
pill.
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 That benefit dropped only slightly
over a year, and side effects — including dizziness and diarrhea —
were similar between those taking the pill or a placebo, researchers
found. One caveat: The pill must be taken on an empty stomach.
The FDA reviewed the drug under its program that promises ultra-fast
reviews for promising medications that serve the public interest.
The pathway was created by then-FDA chief Dr. Marty Makary, who
resigned from the agency in May after months of pressure from
drugmakers, patients and other outside groups.
Heart disease is the nation’s leading cause of death, and high LDL
cholesterol, which causes plaque to build up in arteries, is a top
risk factor for heart attacks and strokes. While an LDL level of 100
is considered fine for healthy people, doctors recommend lowering it
to at least 70 once people develop high cholesterol or heart disease
— and even lower for those at very high risk.
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