FDA Approves New Cholesterol Pill

 

“U.S. regulators approved a first-of-its-kind pill from Merck that is designed to help lower cholesterol levels beyond what statins alone can achieve.

 

The Food and Drug Administration cleared Lipfendra to treat high cholesterol, which is a major risk factor for heart attacks and strokes.

 

The approval was based on studies showing that Merck's once-daily pill reduced bad, or LDL, cholesterol levels by as much as 60% over six months in adults with or at risk for atherosclerotic cardiovascular disease.

 

"The ability to meaningfully reduce LDL well above what you achieve on statins alone, in an easy-to-take pill, we think can really change care in the U.S. and go after one of the biggest killers," said Merck Chief Executive Robert Davis.

 

The product is a pill formulation of a type of drug that has been available for several years as an injection, but wasn't widely adopted at first because of the high price. These drugs, including Amgen's Repatha, target a protein called PCSK9 that interferes with the body's ability to clear the bad form of cholesterol. Repatha now sells $3 billion a year.

 

Merck developed a pill version of a PCSK9 drug to provide a more convenient alternative to injections. The drugmaker is conducting an additional study to see whether Lipfendra's cholesterol-lowering effect also prevents heart attacks and strokes. The new medication can be taken with a statin, an older class of widely used anti-cholesterol drugs.

 

Statins such as Lipitor and Zocor have been credited with significantly reducing a person's risk of heart attack and stroke, but they don't work for everyone, and some people need more help lowering their cholesterol than what statins can provide. There are other newer alternatives as well, including a twice-yearly injection sold by Novartis as Leqvio that uses an RNA-based technology.

 

Merck's new drug will have a list price of $10.50 for each pill, or $315 for a 30-day supply, though the company expects insured patients' out-of-pocket costs to be much lower.

 

Merck also plans to make Lipfendra available at a discounted cash price through TrumpRx.gov, a new government website offering discounts on certain prescription drugs. Merck hasn't set the price for TrumpRx yet.

 

Analysts expect the new Merck pill to be a big seller, generating peak annual sales of more than $5 billion.” [1]

 

Lipfendra could be available in Lithuania at the earliest by late 2027 or 2028. The drug (generic name enlicitide) was approved by the U.S. FDA in mid-July 2026. Merck (MSD) has stated it is awaiting regulatory decisions from authorities in the EU, meaning it must undergo the following process:

•           EMA Approval: The European Medicines Agency (EMA) typically takes 12 to 14 months to review a new medicine, which means it could receive EU-wide marketing authorization in late 2027.

•           Lithuanian Pricing and Reimbursement: Following EMA approval, the drug's manufacturer must apply to the State Medicines Control Agency (VVKT) and the Ministry of Health for national pricing and inclusion in the Lithuanian reimbursement list, which generally adds several more months to the timeline.

 

1. U.S. News: FDA Approves New Cholesterol Pill. Loftus, Peter.  Wall Street Journal, Eastern edition; New York, N.Y.. 17 July 2026: A3.