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Novo Nordisk sells hit weight-loss drug in China—at fraction of US price

By: Beth Mole
19 November 2024 at 17:10

Patients in China will be able to purchase the blockbuster weight-loss drug Wegovy for 1,400 yuan, or about $193, just a fraction of the US list price of $1,349, according to media reports.

The price in China is in line with pricing elsewhere outside of the US. As Sen. Bernie Sanders (I-Vt.) noted in a September Senate hearing, Wegovy, made by Novo Nordisk, is sold for $265 in Canada, $186 in Denmark, $137 in Germany, and just $92 in the United Kingdom. In the hearing, Sanders and other senators grilled Novo Nordisk CEO Lars Jørgensen on the "outrageously high prices" in the US of Wegovy and the company's other popular GLP-1 drug, Ozempic, used for diabetes.

"What we are dealing with today is not just an issue of economics, it is not just an issue of corporate greed. It is a profound moral issue," Sanders said in opening remarks about the prices of the highly effective drugs.

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© Getty | Michael Siluk

Shady drugmaker used code words to sell knockoff weight-loss drug: Lawsuit

By: Beth Mole
22 October 2024 at 22:31

Amid ongoing legal battles over coveted GLP-1 therapies, a drug vendor in Washington state is accused of running an outlandish scheme to sell do-it-yourself kits to make illicit knockoff versions of weight-loss and diabetes drugs, Zepbound and Mounjaro.

For the alleged scheme, vendor Pivotal Peptides has customers buy a set of ingredients they have to mix together to create their own injectable versions of the drugs. Customers don't need a prescription or even a medical consultation to order the kit, even though the brand-name drugs are prescription-only. That may not be surprising, though, since the dubious white powder customers receive is stated to be "a research chemical for lab research and veterinary purposes only." Once purchased, the kit's instructions recommend users disinfect their home work surface before beginning and stress the importance of using the sterile water included in the kit to dissolve the powder to the desired concentration. The instructions then explain how to inject oneself with the homemade mixture using a 30-gauge syringe.

That's all according to a lawsuit filed Monday by pharmaceutical giant Eli Lilly, maker of tirzepatide-based Zepbound and Mounjaro, which are sold as ready-to-use medicines in single-dose pens or vials. The lawsuit against Pivotal Peptides is one of three that Lilly filed this week, all accusing questionable drugmakers of unlawfully selling knockoff versions of its tirzepatide drugs that have not been tested or approved. But the one against Pivotal Peptides stands out for the scheme the owners allegedly used to sell their knockoff version.

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© Getty | Stefan Cristian Cioata

Drugmakers can keep making off-brand weight-loss drugs as FDA backpedals

By: Beth Mole
15 October 2024 at 21:53

Facing a lawsuit, the Food and Drug Administration has decided to reconsider its decision to take popular weight-loss and diabetes drugs off of the national shortage list, which will allow compounding pharmacies to continue selling cheaper copycat versions—at least for now.

A trade organization representing compounding pharmacies sued the agency last week over its October 2 announcement that there was no longer a shortage of tirzepatide drugs, branded as Mounjaro for diabetes and Zepbound for weight loss. The products, members of the extremely popular and effective class of GLP-1 drugs, had been on the shortage list since December 2022.

Being on the list meant that compounding pharmacies were legally allowed to make "essentially copies" of the products; the only time these pharmacies—also called outsourcing facilities—can make imitation versions of approved drugs, such as tirzepatide, is when the products appear on the shortage list. So, with the FDA's announcement, compounders were immediately barred from making any more of the lucrative drugs and had 60 days to fulfill existing orders.

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© Getty | helby Knowles

Drug makers can’t make knockoff weight-loss drugs anymore—and they’re mad

By: Beth Mole
9 October 2024 at 21:17

Compounding pharmacies are suing the Food and Drug Administration so they can keep making imitation versions of popular—and lucrative—tirzepatide drugs, namely knockoffs of Mounjaro for diabetes and Zepbound for weight loss.

Generally, compounding pharmacies make customized formulations of drugs for patients with specific needs, like when a patient has an allergy to a filler ingredient or if a child needs a liquid version of a drug that normally comes as a capsule. But larger compounding operations are also legally allowed to make imitations of branded drugs if those drugs are in short supply, acting as a stopgap for patients.

Tirzepatide has certainly been in short supply in recent years. Given the high prevalence of diabetes and obesity in America and the drug's effectiveness, demand for tirzepatide and other drugs in the new GLP-1 class have skyrocketed, and many patients have struggled to fill prescriptions. The FDA placed tirzepatide on its drug shortage list in December of 2022—and that's where it remained until last week.

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© Getty | Sandy Huffaker

Eli Lilly raises price of Zepbound while trumpeting discount on starter vials

By: Beth Mole
29 August 2024 at 19:59
An Eli Lilly & Co. Zepbound injection pen arranged in the Brooklyn borough of New York, US, on Thursday, March 28, 2024.

Enlarge / An Eli Lilly & Co. Zepbound injection pen arranged in the Brooklyn borough of New York, US, on Thursday, March 28, 2024. (credit: Getty | helby Knowles)

Pharmaceutical giant Eli Lilly earned praise this week with an announcement that it is now selling starter dosages of its popular weight-loss drug tirzepatide (Zepbound) at a price significantly lower than before. But the cheers were short-lived as critics quickly noticed that Lilly also quietly raised the price on current versions of the drug—a move that was notably missing from the company's press release this week.

In the past, Lilly sold Zepbound only in injectable pens with a list price of $1,060 for a month's supply. Several dosages are available—2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, or 15 mg—and patients progressively increase their dosage until they reach a maintenance dosage. The recommended maintenance dosages are 5 mg, 10 mg, or 15 mg. The higher the dose, the more the weight loss. For instance, people using the 15 mg doses lost an average of 21 percent of their weight over 17 months in a clinical trial, while those on 5 mg doses only lost an average of 15 percent of their weight.

On Tuesday, Lilly announced that it will now sell Zepbound in vials, too. And a month's supply of vials with the 2.5 mg doses will cost $399, while a month's supply of 5 mg doses is priced at $549—a welcome drop from the $1,060 price tag. These prices are for a self-pay option, meaning that patients with a valid, on-label prescription can buy them directly from Lilly if they have no insurance or have insurance that does not cover the drug.

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Man suffers heart problem after rapid weight loss: A GLP-1 cautionary tale

By: Beth Mole
5 August 2024 at 22:31
Man suffers heart problem after rapid weight loss: A GLP-1 cautionary tale

Enlarge (credit: Getty | Spauln)

The dose makes the medicine—and for many critical prescription drugs, the dose depends on a patient's body weight. Usually, this is not a problem; weight changes large enough to significantly affect dosages often occur gradually, over periods long enough for doctors to notice and adjust prescriptions. But, in the era of new weight loss drugs, that may no longer be the case.

In a cautionary tale published Monday in JAMA Internal Medicine, researchers at the University of Colorado reported the case of a man who lost nearly 30 percent of his body weight in a six-month period using a new weight loss drug. Then, he showed up at an emergency department with heart palpitations, excessive sweating, confusion, fever, and hand tremors. Tests indicated the man had atrial fibrillation, an irregular heart rhythm that can lead to heart failure and stroke without treatment.

The 62-year-old had no history of atrial fibrillation, but he had previously been diagnosed with obesity, Type 1 diabetes, and hypothyroidism (a condition in which the thyroid gland does not produce enough thyroid hormone). For his hypothyroidism, he took levothyroxine, a synthetic thyroid hormone that is dosed by weight.

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People are overdosing on off-brand weight-loss drugs, FDA warns

By: Beth Mole
26 July 2024 at 21:22
Wegovy is an injectable prescription weight-loss medicine that has helped people with obesity.

Enlarge / Wegovy is an injectable prescription weight-loss medicine that has helped people with obesity. (credit: Getty | Michael Siluk)

The US Food and Drug Administration has approved two injectable versions of the blockbuster weight-loss and diabetes drug semaglutide (Wegovy and Ozempic). Both come in pre-filled pens with pre-set doses, clear instructions, and information about overdoses. But, given the drugs' daunting prices and supply shortages, many patients are turning to imitations—and those don't always come with the same safety guardrails.

In an alert Friday, the FDA warned that people are overdosing on off-brand injections of semaglutide, which are dispensed from compounding pharmacies in a variety of concentrations, labeled with various units of measurement, administered with improperly sized syringes, and prescribed with bad dosage math. The errors are leading some patients to take up to 20 times the amount of intended semaglutide, the FDA reports.

Though the agency doesn't offer a tally of overdose cases that have been reported, it suggests it has received multiple reports of people sickened by dosing errors, with some requiring hospitalizations. Semaglutide overdoses cause nausea, vomiting, abdominal pain, fainting, headache, migraine, dehydration, acute pancreatitis, and gallstones, the agency reports.

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New weight-loss and diabetes drugs linked to lower risk of 10 cancers

By: Beth Mole
9 July 2024 at 15:50
Ozempic is a GLP-1 drug for adults with type 2 diabetes.

Enlarge / Ozempic is a GLP-1 drug for adults with type 2 diabetes. (credit: Getty | Steve Christo)

For patients with Type 2 diabetes, taking one of the new GLP-1 drugs, such as Ozempic, is associated with lower risks of developing 10 out of 13 obesity-associated cancers as compared with taking insulin, according to a recent study published in JAMA Network Open.

The study was retrospective, capturing data from over 1.6 million patients with Type 2 diabetes but no history of obesity-associated cancers prior to the study period. Using electronic health records, researchers had follow-up data for up to 15 years after the patients started taking either a GLP-1 drug, insulin, or metformin between 2008 and 2015.

This type of study can't prove that the GLP-1 drugs caused the lower associated risks, but the results fit with some earlier findings. That includes results from one trial that found a 32 percent overall lower risk of obesity-associated cancers following bariatric surgery for weight loss.

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