FDA approves a first-of-its-kind pill to cut cholesterol in high-risk patients

News

FDA approves a first-of-its-kind pill to cut cholesterol in high-risk patients

2026-07-17 06:25 Last Updated At：06:30

WASHINGTON (AP) — 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 for more than a decade. But patient access has been stymied for years by high prices, insurance restrictions and limited prescribing by doctors.

Statins block some of the liver’s production of cholesterol and are the cornerstone of treatment. But even at the highest doses, many people need additional help lowering their LDL, or bad, cholesterol enough to meet medical guidelines.

Merck, which has headquarters in Rahway, New Jersey, won approval based on two studies in high-risk patients who added the company's pill to their standard treatment, including statins. In one study of 3,000 patients, those taking Lipfendra saw their levels of LDL cholesterol drop more than 55% after six months. In a second study, patients averaged a reduction of 59% compared with patients who received a dummy pill.

That benefit dropped only slightly over a year, and side effects — including dizziness and diarrhea — were similar between those taking the pill or a placebo, researchers found. One caveat: The pill must be taken on an empty stomach.

The FDA reviewed the drug under its program that promises ultra-fast reviews for promising medications that serve the public interest. The pathway was created by then-FDA chief Dr. Marty Makary, who resigned from the agency in May after months of pressure from drugmakers, patients and other outside groups.

Heart disease is the nation’s leading cause of death, and high LDL cholesterol, which causes plaque to build up in arteries, is a top risk factor for heart attacks and strokes. While an LDL level of 100 is considered fine for healthy people, doctors recommend lowering it to at least 70 once people develop high cholesterol or heart disease — and even lower for those at very high risk.

The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education and the Robert Wood Johnson Foundation. The AP is solely responsible for all content.

Texas flash floods leave at least 2 dead in region devastated a year ago

UVALDE, Texas (AP) — Catastrophic flash floods in Texas have killed two people and forced hundreds of rescues in areas still reeling from devastating floods a year ago, Gov. Greg Abbott said Thursday.

Rescuers aboard boats and helicopters have saved more than 200 people, including stranded drivers and people trapped in homes, Abbott said.

The governor said the hardest-hit areas are expecting more rain and are not out of danger yet.

After days of pounding rain, the National Weather Service said a “large and deadly flood wave” barreled down the same river wrecked by flash floods last summer when two dozen children and counselors were killed at Camp Mystic.

Much like last year, the floods came in the middle of the night. But this time some residents in the Texas Hill Country said they received more warnings.

Forecasters urgently warned, “Move to higher ground now!” as rivers rose hour by hour, turning them into fast-moving seas of white water. Some spots of the Guadalupe River rose by more than 30 feet (9 meters).

The governor said more than 1,300 first responders were deployed.

As much as 28 inches (74 centimeters) of rain fell over the past three days in Uvalde County, which was spared from the worst flooding a year ago, the weather service said Thursday. Other areas saw roughly a foot of rain with more expected going into Friday.

“This is hopefully the last real batch of rain,” said Jason Runyen, a meteorologist with the weather service.

While authorities have not released the name of the person who died, Jennie Steward said the body of her husband, 65-year-old John Mark Steward, of Kerrville, was found Thursday.

She was visiting her parents when a neighbor called overnight, saying her husband was missing after water had risen to the door of their mobile home, which stood about 8 feet (2.4 meters) off the ground.

The entire home was swept off the platform and floated down Goat Creek on the Guadalupe River, she said.

“It’s really hard that I wasn’t there with him,” she said. The two were married three years ago and last spoke by phone Wednesday to celebrate their anniversary.

The unfolding crisis brought back haunting memories of last summer's unimaginable Hill Country floods that killed more than 100 people over the July Fourth holiday.

“It’s crazy happening two times in one year,” said Josiah Rodriguez, who awoke to the sound of heavy rain around 2 a.m. Thursday in Kerrville. He navigated flooded roads to help evacuate relatives.

“Last year there was no warning of it,” he said. “It just kind of happened overnight and it took everyone by surprise. This year, a lot more alerts have gone into place, a lot more safety measures.”

Residents said they were caught off guard a year ago and didn’t receive any warning when floods overtopped the Guadalupe. Some local leaders were criticized for not acting quickly.

The storms and flooding this time threatened multiple counties close to the Mexico border and in the Hill Country near San Antonio. Roughly six million residents across Texas were under a flood watch this week, and some were expected to remain in effect through Friday evening.

Several agencies sent rescue helicopters to the flood zone, including Travis County in the state capital of Austin.

“My understanding is people were mostly trapped in trees and on rooftops,” said Travis County Judge Andy Brown, who said one caller warned 10 people were trapped on a barn roof.

At a wild animal rescue, Katie Buck evacuated several dozen animals to higher ground in the dark Thursday as the normally dry Lazy Creek overflowed. She had to quickly grab a porcupine despite having no gloves.

She got all of the animals to safety, but flooding destroyed several enclosures at the Buck Wild Animal Rescue and Wildlife Rehab near Ingram in Kerr County.

“We were just starting to get back on our feet again,” Buck said. “To have to go through this again is just devastating.”

Residents at an RV park in Comfort moved their trailers as sirens sounded, said manager Duke Earwood.

Water rose over the hoods of vehicles parked near the river at the Comfort RV Resort. Markers showed the flooding already matched last July's big flood.

“Too familiar for sure, and too soon,” Earwood said.

Floodwaters also overran the city of Uvalde overnight, cutting off most outside routes. The Leona River, normally dry most of the year, filled streets with water.

“People really can’t get anywhere,” said Carmen Rodriguez, who nervously watched water engulf her neighborhood as a helicopter roared overhead. “We have a place to go, but all the streets are closed.”

Rodriguez said authorities seemed to be well prepared, ordering mandatory evacuations and notifying people directly.

Texas Game Wardens rescued close to 150 people by the afternoon, according to a Texas Parks and Wildlife Department spokesperson. Video released by the agency showed crews hoisting children from a house surrounded with water into a helicopter.

So far, the heavily swollen Guadalupe has remained below the record levels reached in 2025. Gauges showed it rose by more than 30 feet (9 meters) in some spots over just a few hours.

Close to Camp Mystic, which hasn't reopened since last year's tragedy, the Guadalupe near Hunt reached about 20.5 feet (6.3 meters), which is enough to cause flooding, according to U.S. Geological Survey and National Water Prediction Service data.

In Kerr County, where summer camps dot the river's shores, the sheriff’s office said all campers were safe. Several camps said the children were staying inside, with one camp reporting normal flooding.

While the water didn’t rise as high as a year ago in Ingram, Mayor Claud Jordan believes this round of flooding was more widespread in his city. “The rural part of Ingram, all the roads are just trashed,” he said.

“There are a bunch of businesses that haven’t reopened from last year,” Jordan said. “This doesn’t help.”

The Hill Country is especially prone to flash floods because the area’s signature limestone is covered by just a thin layer of soil. During heavy rains, water can quickly shoot downhill before filling the narrow river basins.

Stengle reported from Dallas. Associated Press writers Christopher L. Keller in Albuquerque, New Mexico; Hannah Fingerhut in Des Moines, Iowa; Dave Collins in Hartford, Connecticut; Michael Phillis in Washington; Claudia Lauer in Philadelphia; Kathy McCormack in Concord, New Hampshire; Anna Wilder in Austin, Texas; Laura Turbay in Little Rock, Arkansas; and John Seewer in Toledo, Ohio, contributed.