Weight-Loss Drug Zepbound Faces Supply Issues

One other common weight-loss drug is in brief provide.

Doses of tirzepatide (Zepbound) are few and much between, consultants informed MedPage As we speak, and the injectable had not been listed on the FDA Drug Scarcity Database as of Tuesday. For the reason that publication of this story, nonetheless, the FDA has added Zepbound to the checklist.

One other model of tirzepatide, for kind 2 diabetes (Mounjaro), has been on the FDA scarcity checklist since December 2022.

As prescriptions for the glucagon-like peptide-1 (GLP-1) agonist go unfilled, sufferers are having pandemic flashbacks, in response to one doctor.

Jody Dushay, MD, of Beth Israel Deaconess Medical Heart in Boston, informed MedPage As we speak that one among her sufferers picked up a refill for a GLP-1 agonist and joked that “she felt like she was shopping for bathroom paper throughout COVID; she’s going to take it dwelling on the T [train] and she or he looks like she has to further defend it.”

“There isn’t a Zepbound accessible and [it is] out of inventory. Sufferers have been frantic and it has been chaotic,” Gitanjali Srivastava, MD, of Vanderbilt College Medical Heart in Nashville, Tennessee, informed MedPage As we speak in an electronic mail. “It has to do with provide and demand and the producers have fairly underestimated the demand/provide chain challenge.”

Dushay stated she suspected the scarcity was due partially to insurance coverage protection increasing to incorporate Zepbound after it hit the U.S. market in December 2023. “At first, there wasn’t a lot insurance coverage protection, after which — it is nearly been week to week — extra insurance coverage firms had been approving it,” she stated. “I am getting quite a lot of approvals, far more approvals than denials, I might say, over the previous month, and even roughly over the previous couple of weeks.”

Dushay famous that every one medication on this class, together with the blockbuster semaglutide (Ozempic, Wegovy), have in the end confirmed tough to entry amidst persevering with intermittent shortages. She additionally cautioned that the scenario could worsen if a cardiovascular (CV) indication for tirzepatide is accredited. “If there are knowledge with tirzepatide that present CV profit, much like what they present in Wegovy … I feel the shortages will speed up,” Dushay stated.

Ethan Melillo, PharmD, a senior supervisor of built-in well being at L’Oreal who beforehand labored as a diabetes pharmacist, stated he believes sufferers switching from Wegovy to Zepbound are driving up demand and straining provide.

“There’s extra weight reduction with Zepbound, in order that’s why lots of people are switching, and that is why you most likely noticed the identical factor with Mounjaro,” Melillo informed MedPage As we speak. “Simply because persons are noticing the higher weight reduction, nevertheless it is sensible as a result of [of] the mechanism of motion — the way it does not work simply on GLP-1 but additionally works on GIP [glucose-dependent insulinotropic polypeptide] as effectively.”

Dushay famous that due to “spotty” shortages for the varied step doses of tirzepatide, sufferers have requested her if they will skip a dose. For instance, going from 2.5 mg to 7.5 mg, and bypassing the beneficial 5-mg dose. Extra typically she could take them down a dose, for instance, from 10-mg injections to 7.5 mg, Dushay stated.

An Eli Lilly firm spokesperson informed MedPage As we speak in an electronic mail that “[w]hile Lilly continues to fabricate and ship all doses of Zepbound, as a result of unprecedented demand for these medicines, some sufferers could expertise problem when attempting to fill their prescription at their pharmacy. We acknowledge this case could trigger a disruption in folks’s therapy regimens. …We’re in common contact with the FDA to offer updates on provide, and they’re going to comply with their course of to replace the Drug Shortages Database.”

The FDA didn’t reply to MedPage As we speak’s requests for remark as of press time.

Srivastava identified that “provided that higher than 40% of the U.S. inhabitants has weight problems, these … drugs are extra like aspirin or statins, given their advantages in [cardiovascular] illness and different medical situations, coupled with excessive efficacy in comparison with different FDA-approved weight problems drugs.”