NBC News
Even though Eli Lilly said it has secured supplies of Zepbound, its new weight-loss drug, the drugmaker is now facing widespread shortages just months after its approval. The company says it is working to resolve the problem, but accepts that it is unlikely to find a quick solution, and there is no immediate end to the shortage in sight.
The Food and Drug Administration (FDA) approved the drug in November, introducing a new competitor to Wegovy, the drug from pharmaceutical company Novo Nordisk.
According to the FDA, Zepbound officially became scarce in April, a few months after Eli Lilly CEO Dave Ricks told NBC News that the drug's supply was not a concern. On Wednesday, the FDA website indicated that all but one dose had “limited availability” through the end of June.
Lilly blames the shortage on huge demand for the drug, saying it can't produce enough to meet demand for diabetes and weight loss. Zepbound is the same drug as Mounjaro, the company's diabetes drug, but rebranded for weight loss. Both contain the active substance tirzepatide. Like Zepbound, all but one dose of Mounjaro is in short supply, according to the FDA.
“In the short term, we are going to be in this limited availability, which may cause delays through some of the doses for both Mounjaro and Zepbound,” indicated Rhonda Pacheco, Eli Lilly's vice president for diabetes and obesity: “We are working very “I work hard every day to make sure we increase that capacity as quickly as possible to get them into the hands of patients.”
To increase supply, Eli Lilly said it plans to open a new manufacturing plant in Concord, North Carolina, by the end of the year, dedicated to making Zepbound and Mounjaro, as well as a similar diabetes drug called Trulicity.
The company declined to detail how much it expects to be able to produce. Edgardo Hernández, who heads global manufacturing at Lilly, said patients can expect to see products from the plant on pharmacy shelves “sometime next year.”
“Immensely disturbing”
The shortage means that people like Amanda Cella, 37, of New Jersey, have a hard time finding a pharmacy that still has the medication in stock.
Cella was prescribed Zepbound in February. However, you may not be able to fill your prescription this month. He has contacted retail and hospital pharmacies in New Jersey and Philadelphia, Pennsylvania, but none had the medication.
“I wish I were exaggerating if I said that I have called every Walmart pharmacy in the state of New Jersey,” he explained.
The drug appears to be available on Eli Lilly's telehealth platform, LillyDirect, according to Cella, but it is backordered and there is no word on when it will ship. He has said he has enough doses to last a few weeks, but if he can't find more he will consider a compounding pharmacy, which can carry risks such as incorrect dosing or contamination.
“It's very frustrating”Cella commented.
Christopher McGowan, a gastroenterologist who runs a weight-loss clinic in Cary, North Carolina, says patients who miss more than two weeks of a drug may be forced to start treatment again at the lowest dose and gradually increase it over weeks. to reacclimate.
Starting over can be “immensely disruptive” and “demoralizing” for patients who have successfully lost weight on the drugs, he added.
“On the one hand, it is stressful for the patient, who may have to rush and find a pharmacy that has their dose in stock,” he said. “Likewise, it takes a long time for clinicians and medical teams to help,” he added.
Additionally, abruptly stopping a weight-loss drug can expose patients to weight gain, according to McGowan. “Many patients report an increase in appetite after stopping just one or two doses of the medication,” she added.
Debbie Foley, 56, of Los Angeles, said her hunger levels have increased since she had to reduce her dose of Mounjaro over the past two months because she couldn't fill her prescription.
He has been taking the drug for both diabetes and weight loss. “It's been a great drug,” he says, “I know people know it and that's why everyone wants it, but I hate it when they say, 'Well, we just can't make it fast enough.'”
Be prepared
Lilly has chosen to continue allowing new patients to start taking Zepbound, rather than trying to limit supply to current users, something Novo Nordisk did last year in the midst of a Wegovy shortage by restricting supply of the lowest dose.
The limitation of this so-called starting dose meant that many new patients were unable to start treatment with Wegovy.
“We believe that decision is up to the patient and their healthcare provider,” Pacheco said.
“I always say: be aware and prepare,” he said, “when they put you on treatment with Mounjaro or Zepbound, really make sure you are aware of the limited availability.”
Lilly has a website where patients can track their drug supply. Still, some doctors have had to switch their patients to other drugs because of shortages.
Scott Butsch, director of obesity medicine at the Cleveland Clinic, has had patients who couldn't find Zepbound switch to other weight-loss medications, such as Wegovy.
There are no strict guidelines for switching from Zepbound to Wegovy, or vice versa, according to Butsch, who is currently principal investigator on a trial of another Lilly weight-loss drug.
Some doctors may have their patients gradually reduce the dose of a medication, while others may start taking the new drug immediately. This decision is usually left to the discretion of the doctor.
“Some people felt differently. Others had fewer side effects. While others didn't feel so good. What we know from the changes is that it depends on the person,” said the specialist.
McGowan, who runs the North Carolina weight loss clinic, switched one of her patients, Kathryn Davies, 38, from Wegovy to Zepbound late last year.
Davies said he had had limited success with Wegovy, but Zepbound was doing much better.
Last month, his pharmacy ran out of the medication and told him they didn't know when they would have it back in stock.
“It was a moment of panic,” he recalled, “I've struggled for 30 years to find a solution that really felt like a cure to me, as long as I kept taking it. So it's a little disorienting.”