FDA Latest News: US Government’s Food and Drug Administration Grants Approval to Merck’s Cholesterol Pill Lipfendra – Check Recommended Dosage, Side Effects, Price & More

The Food and Drug Administration has officially approved the usage of Merck’s cholesterol pill, Lipfendra. The pill works by blocking a protein called PCSK9, which reduces the liver's ability to remove LDL cholesterol from the bloodstream.

By: Anushka Singh
Last Updated: July 18, 2026 11:54:32 IST

Cholesterol is one of the most prevalent health issues in the US today, with roughly 1 in 10 adults suffering from high cholesterol (above 250 mg/dL). Now, the Food and Drug Administration has given the nod to Lipfendra, a once daily pill by Merck aimed at tackling cholesterol.

FDA Latest News: FDA Gives Green Light to Merck’s Cholesterol Pill Lipfendra

The Food and Drug Administration officially approved the usage of Merck’s cholesterol pill Lipfendra. The pill, has now become the world’s first once daily pill specifically for cholesterol. The FDA confirmed the news in a press release.  

What is Lipfendra?   

Lipfendra is an oral medication that is meant to be taken once a day. It works by blocking a protein called PCSK9, which reduces the liver’s ability to remove LDL cholesterol from the bloodstream . By blocking the PSCK9 protein, the liver is able to function more efficiently.

Notably, Lipfendra is the first “drug taken by mouth that blocks PCSK9,” as injections are often considered to be expensive or inconvenient. In its statement, the FDA clearly stated that Lipfendra must be strictly used “as a treatment to be used with diet and exercise”. 

Lipfendra Latest News: Price of the Pill 

A Merck spokesperson confirmed that Lipfendra will have a wholesale list price of $10.50 per day, which amounts to exactly $315 for a 30-day supply. The pharma firm also confirmed that it is working on a manufacturer-run coupon program to lower costs. 

Lipfendra Latest News: Recommended Dosage

According to the FDA, the recommended dosage is one 10 mg tablet, taken orally once a day. It should ideally be consumed on an empty stomach, in the morning. Medical professionals have advised patients to wait at least 30 minutes, after taking Lipfendra before consuming any food or beverages.  

Lipfendra Latest News: Potential Side Effects 

According to the clinical trials, Lipfendra is a relatively safe drug. Out of the sample size of more than 3200 adult patients, only some faced diarrhea and dizziness. However these side effects are mild in nature and anyone who faces a severe or allergic reaction should immediately seek medical attention.

Lipfendra Latest News: Where to Buy 

Merck is currently preparing for a commercial rollout regarding Lipfendra’s availability. Once that is established, it will be available to buy from major pharmacies like CVS and Walgreens as well as the government’s direct-to-patient digital platform TrumpRx.gov.  

 

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