New Daily Pill Cuts Bad Cholesterol Nearly 60%

Millions of Americans with high cholesterol just got a game-changing new option that doesn't require a single shot.

The FDA approved Lipfendra on July 16, a once-daily pill that lowers bad cholesterol by nearly 60%. It's the first PCSK9 inhibitor available as a pill instead of an injection, making powerful cholesterol treatment accessible to people who can't or won't use needles.

Dr. Yu-Ming Ni, a cardiologist in California, prescribed the medication to his first patient the day after it became available. The patient was already taking a statin but needed more help and refused injections. "He's like, 'that sounds great, because I don't want to do any injections,'" Ni recalled.

The approval comes after trials involving more than 3,200 adults already taking the highest statin dose they could tolerate. After 24 weeks, Lipfendra lowered LDL cholesterol by 56% in the main study and 59% in people with inherited high cholesterol.

LDL cholesterol, often called bad cholesterol, builds up in arteries and raises the risk of heart attack and stroke. About one in four U.S. adults has high LDL levels, though many don't know it because the condition causes no symptoms.

The Ripple Effect

This breakthrough matters because statins don't work alone for everyone. Some people can't tolerate high doses, and for others, even the maximum dose isn't enough to lower cholesterol to safe levels.

Lipfendra works differently than statins, which is why doctors can prescribe them together. Statins reduce the amount of cholesterol the liver produces, while Lipfendra helps the liver remove more cholesterol from the blood by blocking a protein called PCSK9.

Dr. Anurag Mehta, a preventive cardiologist at Emory Healthcare, explained that the two drugs target different biological pathways to reach the same end result. For patients whose statin isn't enough on its own, the combination could be life-changing.

Three other PCSK9 inhibitors exist, but they all require injections. Two require shots every two weeks at home, and one needs twice-yearly clinic visits. "I have a lot of people who are hesitant to even start because they don't want to give themselves injections," Ni said.

The pill costs about $315 for a 30-day supply, though most patients will pay less through insurance. Merck plans coupon programs for people with commercial insurance and direct-to-patient options for eligible patients.

Side effects were similar to placebo in the first trial, with the most common issues being diarrhea and dizziness. A larger trial testing whether Lipfendra prevents heart attacks and strokes is still underway, but decades of research show that lower cholesterol means lower heart disease risk.

The medication will reach pharmacies within weeks, offering a simpler choice for protecting heart health.