Eli Lilly weight loss drug Zepbound no longer in shortage

The Meals and Drug Administration on Thursday stated the lively ingredient in Eli Lilly’s weight reduction drug Zepbound is no longer in shortage, a call that can finally bar compounding pharmacies from making cheaper, unbranded variations of the injection.

“FDA has decided that the scarcity of tirzepatide injection merchandise, which first started in December 2022, is resolved,” the company stated in a letter. “FDA continues to observe provide and demand for these merchandise.”

The company’s determination, primarily based on a complete evaluation, marks the top of a interval the place sure pharmacies might make, distribute or dispense unapproved variations of tirzepatide – the lively ingredient in Zepbound – with out going through repercussions for violations associated to the remedy’s scarcity standing.

Compounding pharmacies should cease making compounded variations of tirzepatide within the subsequent 60 to 90 days, relying on the kind of facility, the company stated. The FDA stated that transition interval will give sufferers time to modify to the branded model.

It is a blow to some compounding pharmacies, which say their copycat medication assist sufferers who haven’t got insurance coverage protection for Zepbound and may’t afford its hefty price ticket of roughly $1,000 a month. Zepbound and different weight reduction medication aren’t lined by many insurance policy, however Eli Lilly’s diabetes counterpart Mounjaro is.

It is the most recent in a high-stakes dispute between compounding pharmacies and the FDA over a scarcity of tirzepatide, the lively ingredient in each Zepbound and Mounjaro. Eli Lilly has invested billions to develop its manufacturing capability for tirzepatide because it struggles to maintain tempo with unprecedented demand.

A commerce group representing compounding pharmacies — the Outsourcing Services Affiliation — sued the FDA on Oct. 8 over the company’s determination to take away tirzepatide from its official drug shortages checklist simply days earlier. The group alleges the FDA acted with out correct discover, ignoring proof {that a} scarcity of tirzepatide nonetheless exists. It additionally contended that the FDA’s motion was a coup for Eli Lilly that got here on the expense of sufferers.

Following the go well with, the FDA stated it might reevaluate eradicating tirzepatide from the shortages checklist. That allowed compounding pharmacies to proceed making copycats whereas the company reviewed its determination.

Compounded medicines are custom-made options to branded medication designed to satisfy a selected affected person’s wants. When a brand-name treatment is in scarcity, compounding pharmacies can put together copies of the drug in the event that they meet sure necessities underneath federal regulation.

The Meals and Drug Administration doesn’t assessment the security and efficacy of compounded merchandise, and the company has urged consumers to take the permitted, branded GLP-1 medicines when they’re accessible. 

Nevertheless, the FDA does examine some outsourcing amenities that compound medication, in accordance with its website.

Sufferers have turned to compounded variations of tirzepatide amid intermittent U.S. shortages of the branded medication, which carry hefty value tags of $1,000 per 30 days earlier than insurance coverage and different rebates. Many well being plans do not cowl tirzepatide for weight reduction, making compounded variations a extra inexpensive different.

The lively ingredient in Wegovy and Ozempic, semaglutide, has been in intermittent shortages over the previous two years. However the FDA earlier this month stated all doses of these medication at the moment are accessible.

The company has but to announce whether or not it’s eradicating semaglutide from its scarcity checklist — a call that will seemingly have an effect on much more compounding pharmacies since it’s extra extensively used than tirzepatide.

Wegovy, Ozempic, Zepbound and Mounjaro are underneath patent safety within the U.S. and overseas, and Novo Nordisk and Eli Lilly don’t provide the lively elements of their medication to exterior teams. The businesses say that raises questions about what some producers are promoting and advertising to customers.

Novo Nordisk and Eli Lilly have each stepped in to handle illicit variations of their therapies, suing weight reduction clinics, medical spas and compounding pharmacies throughout the U.S. over the previous 12 months. The FDA final month additionally stated it had received reports of sufferers overdosing on compounded semaglutide resulting from dosing errors akin to sufferers self-administering incorrect quantities of a remedy.