CNN
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At Dr. Louis Aronne’s Weight Loss Center in New York City, reactions to new drugs such as Wigoby and Munjaro can be extreme.
“People describe this as ‘miraculous’ and ‘this changed my life,'” said Aronne, director of the Center for Clinical Research in Weight Management and Metabolism at Weill Cornell Medicine.
Rather than “people who are 10 pounds overweight,” his clinic targets people who need to lose a lot of weight or who have multiple weight-related health issues, he said. For those in the former category, “we’re kind of running a miracle clinic,” he said.
But this class of drugs known as GLP-1 receptor agonists is so popular among everyone looking to lose weight that demand outstrips pharmaceutical companies’ manufacturing capacity. And while manufacturers Novo Nordisk and Eli Lilly are competing to expand supply, the impending U.S. Food and Drug Administration approval of Lilly’s type 2 diabetes drug Munjaro as a treatment for obesity will further strain the system. It may cost.
“For the past three to four months, patients have been telling us they can’t get it,” Dr. Jodi Duchey, a clinical endocrinologist at Beth Israel Deaconess Medical Center, said of Munjaro. She prescribes medication for both diabetes and weight loss, so “I’m literally conscious of my drug supply every day.”
Neither Ozempic nor Munjaro are specifically approved for weight loss. The FDA gave the go-ahead to treat type 2 diabetes in 2017 and 2022, respectively. However, doctors usually use them off-label for weight loss. Wigovy, which was approved as an obesity drug in 2021, contains the same main ingredient as Ozempic, called semaglutide, but Maunjaro uses a slightly different drug, tirzepatide.
All three drugs are FDA registered shortage Listed in various places Dose. Novo Nordisk, which manufactures Ozempic and Wegovy, limited Lower doses of Wegovy will be available as Wegovy prioritizes continued supply of the drug to people already using it.Recently the CEO of the company Said CNN said it will take years to catch up with demand.
Lilly and Novo Nordisk are investing billions of dollars to expand production capacity.
Lilly is building two $4 billion factories in North Carolina to double production of so-called incretin drugs, including tirzepatide, which mimics metabolic hormones that affect insulin secretion and appetite, by the end of 2023. are doing. The company anticipates an FDA decision then.Taking Mounjaro for chronic post-clinical weight management ordeal Participants were shown to be able to lose more than 20 percent of their body weight over 72 weeks.
Production is already online at one of two factories in Durham’s Research Triangle Park. The facility uses high-speed automation, unmanned vehicles, and robotic arms to build an auto-injector for Munjaro around a filled syringe. The factory is also preparing a product formulation where the active ingredient, tirzepatide, is mixed with other ingredients to create the finished drug, which is then poured into a syringe.
Lilly said the plant is running 24/7 to meet demand. Still, the synthesis of the starting ingredient, tirzepatide, involves a series of chemical reactions that combine amino acids into peptides, as well as purification and quality control steps, which can take months, the company says. said Director Edgardo Hernandez.
“This is a huge scale of what we are trying to do,” he said. “We are actively working to bring in production capacity.”
Munjaro is on the FDA’s shortage list with a 10-milligram dose, the third-largest dose available. Hernandez said that’s because the way people use the drug differs from Lilly’s predictions.
Munjaro said the starting dose is 2.5 milligrams, and patients can increase the dose every four weeks until they have good blood sugar control. Prescription information. The dose increases up to 15 milligrams.
“We’ve been learning all along,” Hernandez said. “We are using artificial intelligence and machine learning to better predict how patients adjust their doses.”
When it comes to weight loss, results in Lilly’s trial were similar for the 10-milligram and 15-milligram doses, Aronne said. Aronne helped manage research and consulted for several companies developing obesity drugs.
“You can imagine people stopping at 10 o’clock,” he says. “A lot of people will say, ‘I want to have some space in case I need to grow later.'”
These drugs have side effects, the most common of which are gastrointestinal problems such as nausea, vomiting, constipation, and diarrhea, which can make them less appealing at higher doses. It is also associated with a potential risk of causing more severe effects such as gastroparesis.
It may be difficult to get insurance coverage for medicines, and if there is no insurance coverage, Fee Over $1,000 per month out of pocket. Both insurance and supply issues lead to difficult choices for clinicians like Duchey, she said. wrestle Making prescribing decisions knowing that there is not enough medicine.
“All these complexities just make every clinic session really philosophical about things,” she said. “You’re thinking about everyone’s situation in a more subjective way in terms of thinking about who needs these drugs more.”
Aronne said medicine could be more difficult to find in areas where there are many wealthy people who can pay out of pocket. He said that was his experience with patients in Manhattan.
“There are a lot of people like that, like businessmen and lawyers,” he says. “They can potentially afford these things and they go buy them, so the supply is low.”
And while Mounjaro is already being used off-label for weight loss, if Ozempic and Wegovy’s experiences are any indication, demand could increase even more if the FDA approves its use. More than 1.9 million people in the U.S. were prescribed Ozempic in July, and an additional 428,000 were prescribed Wigovy, according to prescribing information from data provider IQVIA.
Lars Fluergaard Jorgensen, CEO of Novo Nordisk, said: “While some may think that we are not producing products due to shortages, we have one of the largest products in the category. “We’re seeing very strong, double-digit percentage point growth.” Said CNN in August. “As such, we are experiencing significant growth and will be making significant investments over the next few years.”
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These investments are expected to return many times over, with investment firm BMO Capital Markets estimating that obesity drugs will generate $100 billion in annual revenue worldwide by 2035.
But until supplies increase, doctors like Duchey are working with patients to lengthen the time between doses or take less at a time if a shortage occurs. She said patients have struggled to find medication for long periods of time and even regained some of the weight they lost.
Lilly said it is working as quickly as possible to address the shortage.
“We’re doing everything we can to maintain supply,” Dan VonDieringen, director of the company’s Research Triangle Park location, told CNN. “It is truly an honor to be able to create medicines that change the lives of patients.”
