Tirzepatide

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There may not be a safe off-ramp for some taking GLP-1 drugs, study suggests

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Of the 308 who benefited from tirzepatide, 254 (82 percent) regained at least 25 percent of the weight they had lost on the drug by week 88. Further, 177 (57 percent) regained at least 50 percent, and 74 (24 percent) regained at least 75 percent. Generally, the more weight people regained, the more their cardiovascular and metabolic health improvements reversed.

Data gaps and potential off-ramps

On the other hand, there were 54 participants of the 308 (17.5 percent) that didn’t regain a significant amount of weight (less than 25 percent.) This group saw some of their health metrics worsen on withdrawal of the drug, but not all— blood pressure increased a bit, but cholesterol didn’t go up significantly overall. About a dozen participants (4 percent of the 308) continued to lose weight after stopping the drug.

The researchers couldn’t figure out why these 54 participants fared so well; there were “no apparent differences” in demographic or clinical characteristics, they reported. It’s clear the topic requires further study.

But, overall, the study offers a gloomy outlook for patients hoping to avoid needing to take anti-obesity drugs for the foreseeable future.

Oczypok and Anderson highlight that the study involved an abrupt withdrawal from the drug. In contrast, many patients may be interested in slowly weaning off the drugs, stepping down dosage levels over time. So far, data on this strategy and the protocols to pull it off have little data behind them. It also might not be an option for patients who abruptly lose access or insurance coverage of the drugs. Other strategies for weaning off the drugs could involve ramping up physical activity or calorie restriction in anticipation of dropping the drugs, the experts note.

In addition to more data on potential GLP-1 off-ramps, the pair calls for more data on the effects of weight fluctuations from people going on and off the treatment. At least one study has found that the regained weight after intentional weight loss may end up being proportionally higher in fat mass, which could be harmful.

For now, Oczypok and Anderson say doctors should be cautious about talking with patients about these drugs and what the future could hold. “These results add to the body of evidence that clinicians and patients should approach starting [anti-obesity medications] as long-term therapies, just as they would medications for other chronic diseases.”

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

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Starts with a T

Pivotal Peptides—which is not a licensed pharmacy or dispensary—did not respond to the letter. Instead, its website was modified to indicate that it was “down for maintenance,” and the company instructed customers to email directly. About 10 days later, Pivotal Peptides’ registered agent, Elizabeth Gately, then sent an email (which Lilly obtained) instructing customers to place tirzepatide orders using coded language.

“Good News,” the email read, “Pivotal Peptides … is still in business!”

“If a favorite product (starting with T) was your go-to, that name can’t be used in any correspondence with me or listed on my price sheet anymore,” Gately allegedly wrote. “Therefore, I need another identifier and decided (for now) to call this peptide ’11mg.'”

Gately went on to say that the codenamed product “is Pivotal Peptide’s [sic] bestseller,” and “it is the only T size available from PP right now except by special order.” The letter ended with: “Remember to order ’11 mg’ with the latest price to identify the product you want, if applicable, and no longer use T in our communication.”

Pivotal Peptides did not respond to Ars’ request for comment.

In a statement emailed to Ars, a Lilly spokesperson said Pivotal Peptides and the other companies Lilly is suing are engaging in “conduct that poses serious risks to patient safety.” In the lawsuit, Lilly notes that even children could be ordering this DIY, research-grade drug.

“No one should ever be allowed to sell these untested, non-human grade or manipulated drugs to American consumers,” the statement continued.

Lilly’s lawsuits come amid a legal storm over compounded versions of the tirzepatide, which can be legally made by licensed pharmacies as long as tirzepatide is in shortage. On October 2, the Food and Drug Administration announced that the shortage had ended but then decided to reconsider the decision after being sued by compounding pharmacies.

On several occasions, the FDA has warned of safety concerns related to compounded versions of GLP-1 weight-loss drugs.

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

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The judge in the case, District Judge Mark Pittman, granted the FDA’s request, canceling an October 15 hearing, and ordering the parties to submit a joint status report on November 21.

Drugmakers respond

The move was celebrated by the Outsourcing Facilities Association (OFA), which filed the lawsuit.

“We believe that this is a fair resolution in light of the agency’s rash decision to take the drug off of the list at a time when the agency has acknowledged ‘supply disruptions,’ which immediately created a major access issue for patients everywhere,” OFA Chairperson Lee Rosebush said in a statement. “Most important, should the FDA repeat its removal decision when a shortage still genuinely exists, we will return to court.”

The move is also likely to please patients who have come to rely on cheaper, more readily available compounded versions of the drugs. For some, compounded products may have been their only access to tirzepatide.  Still, those drugs are not without risk. The FDA has repeatedly emphasized that compounded drugs are not FDA-approved and do not go through the same safety, efficacy, and quality reviews. And the agency has warned of dosing errors and other safety concerns with compounded versions.

The one party that is certainly unhappy with the FDA’s move is Eli Lilly, which had reportedly sent cease-and-desist letters to compounders. In an emailed statement to Ars, a spokesperson for Lilly said that there was sufficient supply of the company’s drug and continued use of compounded versions is unwarranted. “Nothing changes the fact that, as FDA has recognized, Mounjaro and Zepbound are available and the shortage remains ‘resolved,'” the spokesperson said.

Lilly also noted the FDA’s safety concerns about the compounded versions, adding that its own examination of some compounded products found impurities, bacteria, strange coloring, incorrect potency, puzzling chemical structures, and, in one case, a product that was just sugar alcohol.

“All doses of Lilly’s FDA-approved medicines are available and it is important that patients not be exposed to the risks in taking untested, unapproved knockoffs,” the spokesperson said.

In terms of the supply “disruptions” the FDA mentioned and that some patients and pharmacies have reportedly experienced, Lilly said that the supply chain was complex and there are many reasons why a given pharmacy may not have a specific dose at hand, such as limited refrigerated storage space.

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

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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.

On October 2, the FDA announced that the tirzepatide shortage had been resolved and that the nation’s supply of GLP-1 drugs was stabilizing, though other drugs in the class, including semaglutide, remain in short supply.

“FDA confirmed with the drug’s manufacturer [Eli Lilly] that their stated product availability and manufacturing capacity can meet the present and projected national demand,” the agency said in its announcement. However, it cautioned that patients and prescribers “may still see intermittent localized supply disruptions” as the drugs move through the supply chain.

End of an era

With the resolution, compounding pharmacies are no longer able to produce tirzepatide. And the FDA highlighted the point to the drug makers, writing in bold that the agency “reminds compounders of the legal restrictions on making copies of FDA-approved drugs.”

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