FDA Approves Revolutionary Cholesterol Medication by Merck

WHO:

Fox News - Dr. Marc Siegel, Fox News senior medical analyst, stated, "PCSK-9 is a protein that works in the liver, preventing the recycling of LDL receptors, as a result increasing bad cholesterol in the blood."

Fox News - Steve Nissen, longtime head of preventive cardiology at Cleveland Clinic, emphasized, "the lower the better when it comes to LDL cholesterol, especially in those at risk for heart disease."

Fox News - Merck is the manufacturer of Lipfendra (enlicitide).

CNN - The U.S. FDA is the regulatory body that approved Lipfendra.

WHAT:

ABC News - Lipfendra will carry a list price of about $300 a month, compared to roughly $500 for comparable injectables.

ABC News - The drug is expected to hit pharmacies in the coming weeks, but patients will need to check with their insurance to see what they'll actually pay.

ABC News - In clinical trials, Lipfendra cut LDL levels by 56% to 59% compared to a placebo.

ABC News - The FDA's decision was based on two late-stage trials showing significant LDL cholesterol reduction in a broad range of patients.

ABC News - Lipfendra will carry a list price of about $300 a month, compared to roughly $500 for comparable injectables.

ABC News - The drug is expected to hit pharmacies in the coming weeks, but patients will need to check with their insurance to see what they'll actually pay.

ABC News - In clinical trials, Lipfendra cut LDL levels by 56% to 59% compared to a placebo.

Fox News - Lipfendra is approved as an add-on to diet and other LDL-lowering therapies in adults with high cholesterol, including inherited forms of high cholesterol.

Fox News - The approval of Lipfendra is expected to provide a new treatment option for millions of Americans with high cholesterol.

Fox News - Lipfendra is approved for patients with inherited forms of high cholesterol and those who do not see enough benefit from statins alone.

CNN - The FDA's decision was based on two late-stage trials that showed significant LDL cholesterol reduction in patients with familial hypercholesterolemia and those already taking statins.

Fox News - The approval of Lipfendra is expected to provide a new treatment option for millions of Americans with high cholesterol.

Fox News - The FDA's approval of Lipfendra allows it to be used as an add-on to diet and other LDL-lowering therapies in adults with high cholesterol, including inherited forms of high cholesterol.

CNN - About one in four adults in the U.S. have high LDL cholesterol, according to the American Heart Association.

Fox News - The pill was generally well-tolerated in the trials, with the most common side effects being diarrhea and dizziness.

Fox News - The most common side effects of Lipfendra reported in clinical trials were diarrhea and dizziness.

Fox News - Serious side effects and treatment discontinuations occurred at rates similar to those in the placebo group during the trials.

Fox News - The FDA's approval of Lipfendra allows it to be used as an add-on to diet and other LDL-lowering therapies in adults with high cholesterol, including inherited forms of high cholesterol.

Fox News - In clinical trials, Lipfendra was shown to reduce LDL cholesterol by approximately double the impact of statins.

CNN - Scotiabank analyst Louise Chen stated that Lipfendra could have “peak sales potential of tens of billions of dollars.”

Fox News - The FDA has approved Lipfendra, the first once-daily oral PCSK9 inhibitor.

CNN - Lipfendra is intended to treat patients with hypercholesterolemia, characterized by elevated levels of LDL cholesterol.

Fox News - In phase 3 clinical trials, Lipfendra reduced LDL cholesterol by roughly 56% to 60% when combined with statin therapy.

CNN - The FDA's decision was based on two late-stage trials showing significant LDL cholesterol reduction in a broad range of patients.

WHERE:

Fox News - Merck is based in New Jersey.

CNN - The approval was granted by the U.S. FDA.

WHEN:

Fox News - Results from a large clinical trial to determine Lipfendra's impact on heart attacks, strokes, and cardiovascular deaths are expected to be available in 2029.

CNN - Results from a large clinical trial to determine Lipfendra's impact on heart attacks, strokes, and cardiovascular deaths are expected to be available in 2029.

WHY:

CNN - The approval of Lipfendra bolsters Merck's efforts to diversify beyond its cancer treatment Keytruda, which is set to lose key patent protections starting in 2028.

CNN - The approval of Lipfendra is part of Merck's strategy to diversify its portfolio as Keytruda is set to lose key patent protections starting in 2028.

CNN - The approval of Lipfendra bolsters Merck's efforts to diversify beyond its cancer treatment Keytruda, which is set to lose key patent protections starting in 2028.

HOW:

ABC News - Lipfendra works by inhibiting a protein called PCSK9, which normally stops the body from clearing LDL from the blood.

CNN - Lipfendra is a recipient of the FDA commissioner’s National Priority Voucher program, which is designed to expedite the review periods of drugs critical to public health or national security.

Fox News - Lipfendra is the first oral PCSK9 inhibitor, providing an alternative to injectable cholesterol-lowering drugs.

CNN - Lipfendra works by blocking the PCSK9 protein, which plays a vital role in regulating cholesterol levels.

CNN - Lipfendra is the first oral PCSK9 inhibitor to enter the market, providing an alternative to injectable cholesterol-lowering drugs.

CNN - Lipfendra is a recipient of the FDA commissioner’s National Priority Voucher program, which is designed to expedite the review periods of drugs critical to public health or national security.

Fox News - Lipfendra works by blocking the action of PCSK9, a protein that affects how the liver removes LDL cholesterol from the bloodstream.

CNN - Oral statins block an enzyme the liver uses to make cholesterol, while Lipfendra targets the PCSK9 protein.

(UPDATED July 17, 2026 14:27 UTC)

Lipfendra, a new drug that inhibits a protein called PCSK9 to help clear LDL cholesterol from the blood, is set to be available at pharmacies in the coming weeks with a list price of about $300 a month, significantly lower than the roughly $500 for comparable injectables. In clinical trials, Lipfendra demonstrated impressive results, cutting LDL levels by 56% to 59% compared to a placebo, which played a key role in the FDA's approval based on two late-stage trials. Patients are advised to check with their insurance providers to determine their actual out-of-pocket costs for this new treatment.

(UPDATED July 17, 2026 10:30 UTC)

A new drug called Lipfendra is set to launch in pharmacies soon, with a list price of about $300 a month, significantly lower than the roughly $500 for similar injectables. In clinical trials, Lipfendra demonstrated impressive results, reducing LDL levels by 56% to 59% compared to a placebo, and it works by inhibiting a protein called PCSK9 that typically prevents the body from clearing LDL from the blood. Patients are advised to check with their insurance to determine their actual out-of-pocket costs once the drug becomes available.

(UPDATED July 17, 2026 02:53 UTC)

Lipfendra has been approved as an add-on treatment for adults with high cholesterol, including those with inherited forms of the condition, offering a new option for millions of Americans. Dr. Marc Siegel, a senior medical analyst at Fox News, explained that this medication targets a protein in the liver that affects bad cholesterol levels, while Steve Nissen from the Cleveland Clinic emphasized the importance of lowering LDL cholesterol for those at risk of heart disease. Results from a large clinical trial assessing Lipfendra's effects on heart attacks, strokes, and cardiovascular deaths are anticipated to be released in 2029.

(UPDATED July 16, 2026 21:19 UTC)

Lipfendra has been approved for patients with inherited forms of high cholesterol and those who do not see enough benefit from statins alone, offering a new treatment option for millions of Americans. This decision by the FDA was based on two late-stage trials that demonstrated significant reductions in LDL cholesterol for patients with familial hypercholesterolemia and those already on statins. Notably, Lipfendra is the first oral PCSK9 inhibitor, providing an alternative to injectable cholesterol-lowering medications.

(UPDATED July 16, 2026 20:15 UTC)

The FDA has approved Lipfendra for use as an add-on to diet and other LDL-lowering therapies in adults with high cholesterol, including inherited forms. According to the American Heart Association, about one in four adults in the U.S. have high LDL cholesterol, highlighting the significance of this new treatment. In clinical trials, Lipfendra was generally well-tolerated, with the most common side effects reported as diarrhea and dizziness.

(UPDATED July 16, 2026 19:22 UTC)

Merck has received approval for Lipfendra, which is the first oral PCSK9 inhibitor to hit the market, offering a new option for those looking to lower cholesterol without injections. Clinical trials revealed that the most common side effects reported were diarrhea and dizziness, with serious side effects and treatment discontinuations occurring at rates similar to the placebo group. This move is part of Merck's strategy to diversify its portfolio, especially as Keytruda is set to lose key patent protections starting in 2028.

(UPDATED July 16, 2026 17:22 UTC)

The FDA has approved Lipfendra for use as an add-on treatment for adults with high cholesterol, including those with inherited forms of the condition. Clinical trials have shown that Lipfendra can reduce LDL cholesterol by approximately double the impact of statins, and Scotiabank analyst Louise Chen has noted its potential for peak sales in the tens of billions of dollars. This approval is part of the FDA commissioner’s National Priority Voucher program, aimed at speeding up the review of drugs that are crucial for public health or national security.

(UPDATED July 16, 2026 14:38 UTC)

The U.S. FDA has approved Lipfendra, the first once-daily oral PCSK9 inhibitor developed by Merck, which is based in New Jersey. This new treatment is designed for patients with hypercholesterolemia, and in phase 3 clinical trials, it demonstrated a reduction in LDL cholesterol by approximately 56% to 60% when used alongside statin therapy. Results from a large clinical trial assessing Lipfendra's effects on heart attacks, strokes, and cardiovascular deaths are expected to be available in 2029.