FDA approves Merck’s once-daily Lipfendra, a PCSK9 inhibitor pill for high LDL cholesterol

Lipfendra, a new once-daily pill for high cholesterol, can be taken instead of or alongside a statin. Iryna Veklich · Moment / Getty Images The FDA has approved Lipfendra, a new drug for adults with high LDL cholesterol. It is the first PCSK9 inhibitor in its class to come as a pill; the other three treatments require shots. Lipfendra can be taken instead of or alongside a statin to lower high LDL cholesterol. People with high cholesterol levels now have a new treatment option: a once-daily pill.The Food and Drug Administration (FDA) approved Lipfendra (enlicitide) on July 16 to lower low-density lipoprotein (LDL) cholesterol in adults with high cholesterol. LDL cholesterol — often called “bad” cholesterol — builds up in the arteries and raises the risk of heart attack, stroke, and artery diseases, according to the American Heart Association (AHA). Most people who need cholesterol medication start with a statin, according to the AHA. However, statins don’t always do the job on their own. How well people tolerate statins varies from person to person, and the highest tolerated dose isn’t always enough to lower their cholesterol to a safe level. That’s where drugs like Lipfendra come in. Lipfendra can be used in addition to or instead of a statin to lower LDL through a different mechanism. The trials leading to Lipfendra’s approval tested the drug in individuals taking statins. The prescribing info for the drug states that this PCSK9 inhibitor can be used as an adjunct therapy to diet and exercise to lower LDL cholesterol in adults with high blood pressure. Here’s why experts say the new pill could revolutionize treatment. Lipfendra: A once-daily pill for ‘bad’ cholesterol As a daily pill, Lipfendra provides those with high cholesterol an alternative to needles.“Being able to have an oral version of this medication is really important,” said Yu-Ming Ni, MD, a cardiologist and lipidologist at MemorialCare Heart and Vascular Institute at Orange Coast Medical Center in Fountain Valley, CA.“I have a lot of people who are hesitant to even start because they don’t want to give themselves injections,” Ni told Healthline. “Now you’ve got this oral version. It’s going to be a little bit easier for people to take a pill every day.”Because Lipfendra works differently from a statin, people can use both medications. Anurag Mehta, MD, a preventive cardiologist at Emory Healthcare and assistant professor of medicine at Emory University School of Medicine, said the two drugs target “two different biological pathways” to reach “the same end result” — lower LDL cholesterol. For individuals whose statin isn’t enough on its own, “those patients would be candidates for this new medicine,” Mehta said. Lipfendra lowers LDL levels by nearly 60% Lipfendra’s approval rests on two trials that together enrolled more than 3,200 adults already taking the highest statin dose they could tolerate, the FDA said in a release. After 24 weeks, the drug lowered LDL cholesterol by about 56% in the main study and 59% in a second study focused on people with an inherited form of high cholesterol. Ni called the reductions “quite impressive.”The trials measured how much Lipfendra lowers cholesterol, not whether it prevents heart attack and stroke. A larger trial testing that question is still underway. The FDA told Healthline it accepts a drop in LDL-C as a validated stand-in for lower cardiovascular risk.Ni noted the distinction but pointed to the broader evidence.“We have tons of data showing that the lower the cholesterol you go, the lower your risk for heart disease,” he said.In the first trial, side effects occurred about as often as with a placebo. In the second trial, patients most often reported diarrhea and dizziness, the FDA release said. Ni said he prescribed Lipfendra to his first patient the day after it became available. He said the patient was already on a statin and needed more help but wanted nothing to do with injections. “He’s like, ‘that sounds great, because I don’t want to do any injections,’” Ni recalled. Lipfendra vs. other cholesterol treatments Statins and Lipfendra lower LDL cholesterol by different routes, which is why a doctor can prescribe them together. Statins reduce the amount of cholesterol the liver produces, while Lipfendra helps the liver remove more cholesterol from the blood. It does this by blocking a protein called PCSK9.Lipfendra is the fourth PCSK9 inhibitor to win FDA approval, and the first in pill form. The others are injections — evolocumab and alirocumab, typically given every two weeks at home, and inclisiran, administered twice a year in the clinic. All of them lower LDL cholesterol by 50% to 60%, according to patient data. Mehta told Healthline that the choice comes down to personal preference.“What does the patient want?” Mehta said. “Are they comfortable with giving themselves an injection every two weeks? Do they want to come to the office and get a shot twice a year? Or do they just want to take a pill?” How much does Lipfendra cost? Lipfendra’s list price is $10.50 a day, or about $315 for a 30-day supply, according to a spokesperson for Merck, the drug’s manufacturer. The spokesperson told Healthline that most patients, including those on Medicare, will pay less out of pocket than the list price. The company said they also plan a coupon program for people with commercial insurance and a direct-to-patient option for eligible patients. How much patients actually pay will depend heavily on insurance. Merck said Lipfendra will reach pharmacies within weeks. High cholesterol impacts 1 in 4 adults The American Heart Association (AHA) estimates that 1 in 4 U.S. adults has high LDL cholesterol. High cholesterol usually causes no symptoms, so many people don’t learn their level is high until a blood test reveals it, according to the Centers for Disease Control and Prevention (CDC). In March, the AHA, the American College of Cardiology (ACC), and nine other medical organizations updated their cholesterol guidelines to push for lower targets and earlier treatment.Under the updated goals: People at borderline or intermediate risk of a first heart attack or stroke should aim for an LDL cholesterol below 100 mg/dL. People at high risk should aim for below 70 mg/dL. People who already have cardiovascular disease and are at a high risk of heart attack or stroke should aim for below 55 mg/dL. “We are targeting numbers less than 55 milligrams per deciliter per the new cholesterol guidelines,” Mehta said, “and in those circumstances, the statin medications many times — even at the highest tolerable dose — are not enough.” Diet, lifestyle matters for cholesterol management Both doctors agreed that lifestyle comes first. “The biggest impact on cholesterol levels is diet,” Ni said. Mehta pointed to a Mediterranean diet which prioritizes: lean proteins like chicken, fish and legumes high fiber foods — fruits, vegetables and whole grains Cutting back on saturated and trans fats, found in red meat, full-fat dairy and deep-fried foods adding omega-3-rich foods like fish, which may help lower LDL Mehta recommended at least 150 minutes of aerobic activity per week, plus strength training, for cholesterol management and overall health. 

WASHINGTON — 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 […]...Keep on reading: US FDA approves novel cholesterol pill for high-risk patients

Federal regulators approved a first-of-its-kind cholesterol medication from Merck that rivals the effectiveness of powerful drugs already on the market. The Food and Drug Administration (FDA) greenlit the once-daily pill called Lipfendra. Lipfendra reduces “bad,” or low-density lipoprotein cholesterol (LDL-C) in adults by inhibiting the production of PCSK9 proteins. Lipfendra is the first drug that...

The pill, branded as Lipfendra, is intended to treat patients with hypercholesterolemia, including those with ​hereditary forms of the disease, which causes elevated levels of LDL.

Lipfendra can be taken in conjunction with or an alternative to statins, the most prescribed medication in the USSign up for the Breaking News US newsletter email The drug giant Merck on Thursday announced it had received FDA approval for a daily pill that can be an alternative to statins for treating high LDL levels, or so-called bad cholesterol. The new pill, Lipfendra, is a version of a drug called a PCSK9 inhibitor.For decades the go-to therapy to treat high cholesterol levels has been statins, the most prescribed medication in the US. But statins come occasionally with side-effects like muscle aches and they sometimes don’t drop cholesterol levels enough to meet recommended levels. Continue reading...

The FDA has approved Lipfendra, a new daily oral medication for high cholesterol. This drug belongs to a newer class of medicines called PCSK9 inhibitors. Lipfendra works by helping the liver remove more bad cholesterol from the blood. It offers an easier alternative for patients who previously needed injections. This approval provides a valuable new option for managing difficult cholesterol levels.