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The shortage of Eli Lilly’s (LLY+2.06%) blockbuster diabetes and weight loss drugs is officially over, according to the U.S. Food and Drug Administration (FDA).
The FDA updated its drug shortage database on Wednesday, marking the popular drugs’ shortages as resolved. The news could put pressure on companies that have been able to sell off-brand versions of GLP-1 weight loss drugs due to widespread shortages.
GLP-1 drugs, which mimic hormones that regulate blood sugar and suppress appetite, have become highly sought after for their weight loss effects. Soaring demand for these treatments have transformed Eli Lilly and its rival Novo Nordisk (NVO+0.02%), the maker of Ozempic and Wegovy, into the most valuable pharma companies in the world. Skyrocketing demand has made it difficult for some patients to fill their prescriptions.
Eli Lilly’s Mounjaro was added to the FDA’s drug shortage database in 2022, while Zepbound was added this April.
“Because Lilly’s FDA-approved medicines are available, patients should not be exposed to the higher risks posed by untested, unapproved knockoffs,” an Eli Lilly spokesperson told Quartz in an emailed statement. “The entities currently mass-producing and mass-marketing compounded and counterfeit tirzepatide need to stop immediately.”
Low-cost competitors aren’t thrilled
The millennial-focused telehealth platform Hims & Hers (HIMS+7.01%), which recently began offering a compounded version of semaglutide — the active ingredient in Wegovy — saw its stock drop by over 11% during Wednesday’s trading session.
Compounding refers to the customization of an approved drug by a pharmacy or physician to meet the specific needs of an individual patient.
Typically, the Food, Drug, and Cosmetic Act prohibits compounding drugs that are just copies of commercially available medications. But drugs that are in shortage are not considered by the FDA to be commercially available. The limited supply of highly coveted and expensive brandname weight loss drugs has spurred several digital healthcare companies to take advantage of that provision.
Hims & Hers did not immediately respond to a request for comment.
In July, the company added Kåre Schultz, a longtime Novo Nordisk executive, to its board of directors. At the time, Schultz told Bloomberg that the company has a “long future” in selling compounded semaglutide.
When asked if pharmacies will still be able to make compounded semaglutide after the shortages end, Schulz said he wasn’t worried because there would still be cases where patients need individualized prescriptions.
Geoff Cook, CEO of the weight loss app Noom, which recently began offering compounded semaglutide to its members, urged regulators in September to proceed cautiously when considering lifting the shortage declaration for brandname weight loss drugs. He warned that ending the declaration too soon could restrict consumers’ access to more affordable alternatives.
“We just continue to urge policy makers to take into account the fact that patients losing access to their medication is not a good thing and especially losing it over night would be not a good thing,” Cook told Quartz on Wednesday.
If and when the FDA declares an end to the semaglutide shortage, Cook said Noom would continue offering branded GLP-1 treatments and other weight loss medications to its members. The company may also explore offering even more customized compounded versions of semaglutide that can be taken sublingually, instead of by injection. Additionally, Cook supports efforts by Rep. Lloyd Doggett and Sen. Elizabeth Warren and has urged Health and Human Services Secretary Xavier Becerra to help lower the cost of semaglutide by using existing law to allow for generic competition, ahead of patent expirations.
In the short term, Cook expects patients who were on compounded tirzepatide to switch over to a compounded semaglutide treatment.