US regulators approve Wegovy pill for weight loss

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By JONEL ALECCIA

U.S. regulators on Monday gave the green light to a pill version of the blockbuster weight-loss drug Wegovy, the first daily oral medication to treat obesity.

The U.S. Food and Drug Administration’s approval handed drugmaker Novo Nordisk an edge over rival Eli Lilly in the race to market an obesity pill. Lilly’s oral drug, orforglipron, is still under review.

Both pills are GLP-1 drugs that work like widely used injectables to mimic a natural hormone that controls appetite and feelings of fullness.

In recent years, Novo Nordisk’s injectable Wegovy and Lilly’s Zepbound have revolutionized obesity treatment globally and in the U.S., where 100 million people have the chronic disease.

The Wegovy pills are expected to be available within weeks, company officials said. Availability of oral pills to treat obesity could expand the booming market for obesity treatments by broadening access and reducing costs, experts said.

About 1 in 8 Americans have used injectable GLP-1 drugs, according to a survey from KFF, a nonprofit health policy research group. But many more have trouble affording the costly shots.

“There’s an entire demographic that can benefit from the pills,” said Dr. Fatima Cody Stanford, a Massachusetts General Hospital obesity expert. “For me, it’s not just about who gets it across the finish line first. It’s about having these options available to patients.”

The Novo Nordisk obesity pill contains 25 milligrams of semaglutide. That’s the same ingredient in injectables Wegovy and Ozempic and in Rybelsus, a lower-dose pill approved to treat diabetes in 2019.

In a clinical trial, participants who took oral Wegovy lost 13.6% of their total body weight on average over about 15 months, compared with a 2.2% loss if they took a placebo, or dummy pill. That’s nearly the same as injectable Wegovy, with an average weight loss of about 15%.

Chris Mertens, 35, a pediatric lung doctor in Menomonee Falls, Wisconsin, joined the Novo Nordisk trial in 2022 and lost about 40 pounds using the Wegovy pill. The daily medication worked to decrease his appetite and invasive thoughts of food, he said.

“If there were days where I missed a meal, I almost didn’t realize it,” Mertens said.

Participants in a clinical trial who took the highest dose of Lilly’s orforglipron lost 11.2% of their total body weight on average over nearly 17 months, compared with a 2.1% loss in those who took a placebo.

Both pills resulted in less weight loss than the average achieved with Lilly’s Zepbound, or tirzepatide, which targets two gut hormones, GLP-1 and GIP, and led to a 21% average weight loss.

All the GLP-1 drugs, oral or injectable, have similar side effects, including nausea and diarrhea.

Both daily pills promise convenience, but the Wegovy pill must be taken with a sip of water in the morning on an empty stomach, with a 30-minute break before eating or drinking.

That’s because Novo Nordisk had to design the pill in a way that prevented the drug from being broken down in the stomach before it could be absorbed by the bloodstream. The drugmaker added an ingredient that protects the medication for about 30 minutes in the gut and makes it easier to take effect.

By contrast, Lilly’s orforglipron has no dosing restrictions. That drug is being considered under the FDA’s new priority voucher program aimed at cutting drug approval times. A decision is expected by spring.

Producing pills is generally cheaper than making drugs delivered via injections, so the cost for the new oral medications could be lower. The Trump administration earlier this year said officials had worked with drugmakers to negotiate lower prices for the GLP-1 drugs, which can cost upwards of $1,000 a month.

The company said the starting dose would be available for $149 per month from some providers. Additional information on cost will be available in January.

It’s not clear whether daily pills or weekly injections will be preferred by patients. Although some patients dislike needles, others don’t seem to mind the weekly injections, obesity experts said. Mertens turned to injectable Zepbound when he regained weight after the end of the Wegovy pill clinical trial.

He said he liked the discipline of the daily pill.

“It was a little bit of an intentional routine and a reminder of today I’m taking this so that I know my choices are going to be affected for the day,” he said.

Dr. Angela Fitch, an obesity expert and chief medical officer of knownwell, a health care company, said whatever the format, the biggest benefit will be in making weight-loss medications more widely accessible and affordable.

“It’s all about the price,” she said. “Just give me a drug at $100 a month that is relatively effective.”

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.

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Feds seek $5.2M restitution from founder of Feeding Our Future

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Federal prosecutors have asked a judge to order the ringleader of the $250 million Feeding Our Future scandal, the largest known pandemic-era fraud scheme in Minnesota, to pay millions of dollars in restitution.

Aimee Bock, 45, should pay $5.2 million for her involvement in the scheme, prosecutors said in a Dec. 19 court filing requesting a judge to issue a forfeiture order. Most of the money prosecutors are seeking is in a $3.5 million Bank of America account seized by the government during its investigation.

Bock was convicted earlier this year for stealing federal money from the state through fraudulent meal reimbursement claims to the Minnesota Department of Education. The money was supposed to provide meals to children in need during the COVID-19 crisis.

Bock and 77 others were accused of claiming nearly a quarter-billion dollars in reimbursements for millions of meals they never served. More than 50 defendants have been convicted as of mid-December, but less than half of the money has been recovered.

“As the Director and sole person in control of FOF, Bock was the indispensable leader of the food program fraud scheme and conspiracy,” FBI forensic accountant Pauline Roase wrote in the forfeiture filing. “She submitted all or nearly all of the claims that caused those payments to be made.”

Bock, co-defendant, remain in custody

Bock and codefendant Salim Ahmed Said, co-owner of the now-closed Safari Restaurant in Minneapolis, which was one of the main locations for fraudulent claims, were convicted in March.

Bock and Said, who was 36 at the time of his conviction in March, have not yet been sentenced and remain in custody.

The remainder of the $5.2 million restitution request against Bock seeks payments for various deposits and payments made to entities tied to the scheme as well as “bribes and kickbacks” related to fraud.

At trial this year, prosecutors said Bock had pocketed about $2 million.

Recovering funds

There has been some progress in recovering stolen money since the first charges in the Feeding Our Future case in September 2022.

Assistant U.S. Attorney Joe Thompson, who has been leading the federal prosecutions in Minnesota fraud cases, said on Thursday that approximately $60 million to $70 million had been recovered so far.

Of that amount, around $30 million is cash from bank accounts, Thompson said. The remainder is in real estate and vehicles.

“We seize assets from many people if they have money in bank accounts. We’re very aggressive in seizing those funds if they purchase real estate, especially if they purchased it without financing,” he told reporters at a news conference announcing charges in Medicaid fraud cases. “There’s many multimillion-dollar properties that were purchased outright with no financing, no mortgage. And so we’re going to get a considerable amount back on that.”

The overall recovery estimate amount is up from $50 million in October 2024.

Unclear how much money will be recovered

It’s unclear just how much of the money the federal government will be able to recover from the Feeding Our Future defendants or those charged in the Medicaid-related schemes this year.

Some of the Feeding Our Future defendants’ circumstances illustrate the challenge.

Mohamed Jama Ismail, convicted at trial last year on charges of wire fraud conspiracy and money laundering, took about $2 million, according to federal prosecutors.

Ismail was sentenced Tuesday to 12 years in prison and was ordered by the judge to pay restitution. But at least $850,000 may never be recovered because it’s out of the reach of U.S. authorities in Chinese investments and real estate in Kenya and Somalia.

“He has never agreed to return the federal child nutrition program funds he sent abroad back to the United States,” prosecutors wrote in a sentencing memo. “Because of his crime, he will leave prison a wealthy man.”

In another case, defendants Said Ereg and his wife, Najmo Ahmed, operators of Evergreen Grocery and Deli in South Minneapolis, got more than $4.2 million in reimbursements and sent $2.5 million to accounts controlled by foreign companies, according to prosecutors.

New fraud cases

Last week, federal prosecutors announced six new charges in alleged schemes tied to state-administered Medicaid programs. Thompson described fraud in Minnesota as “industrial scale” and estimated half or more of the $18 billion paid out since 2018 in 14 “high-risk” programs could have been lost to fraud.

Gov. Tim Walz, who has come under increasing pressure to address fraud in government programs, said he hadn’t seen any evidence of that scale of theft.

Officials with the state Department of Human Services continued to push back against Thompson’s estimate at a Monday briefing, saying the U.S. Centers for Medicare and Medicaid Services had never raised concerns about that level of fraud.

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“I could see potentially there being hundreds of millions of dollars of fraud in our programs if you stretch that out through several years,” said DHS Inspector General James Clark.

“No one at DHS has previously heard anything from our federal partners at CMS or otherwise even remotely approaching the $9 billion figure.”

Vikings list J.J. McCarthy as a DNP. Will he play on Christmas Day?

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It’s still unclear if quarterback J.J. McCarthy will be available when the Vikings host the Detroit Lions on Christmas Day.

He suffered a right hand injury shortly before halftime on Sunday afternoon at MetLife Stadium and was not available for the Vikings as they grinded out a 16-13 win over the New York Giants.

Though the Vikings didn’t actually practice on Monday afternoon at TCO Performance Center, they are required by the NFL to release an estimated injury report. They listed McCarthy as a non participant with a right hand injury, which, in turn, raises questions about his availability moving forward.

The other non participants for the Vikings included running back Jordan Mason (ankle), tight end, T.J. Hockenson (shoulder), center Ryan Kelly (concussion), and right tackle Brian O’Neill (heel).

It will be interesting to hear what head coach Kevin O’Connell has to say on Tuesday afternoon at TCO Performance Center when he’s scheduled to talk to reporters. He didn’t have much information about McCarthy immediately after the Vikings beat the Giants.

If McCarthy is unable to go for the Vikings against the Lions, rookie quarterback Max Brosmer will step in as the starter.

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Emergency officials respond to a small plane crash near Galveston, Texas

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GALVESTON, Texas (AP) — Emergency crews in Texas are responding to a small plane crash near Galveston, officials said.

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The crash took place Monday near the base of a causeway near Galveston, which is located on the Gulf of Mexico about 50 miles southeast of Houston.

Officials from the Federal Aviation Administration were expected to arrive at the scene of the crash, the Texas Department of Public Safety said in a post on the social platform X.

It was not immediately clear how many people were aboard or whether there had been any injuries.

The Galveston County Sheriff’s Office said officials from its dive team, crime scene unit, drone unit and patrol were responding to the crash.

“The incident remains under investigation, and additional information will be released as it becomes available,” the sheriff’s office said in a post on Facebook, adding that the public should avoid the area so emergency responders can work safely.

Galveston is an island that is a popular beach destination.