After an FDA approval last year, Eli Lilly’s diabetes drug Mounjaro has been on fire right out of the gate. Now, the Indianapolis pharma giant says it's resolved a months-long shortage.
Lilly has satisfied wholesalers’ backorders for Mounjaro and is continuingly shipping all six doses of the diabetes med, a company spokesperson said.
Still, it’s too early to say the shortage of Mounjaro has completely ended. The FDA still lists Mounjaro on its drug shortage list as of an update Tuesday, although the agency doesn’t flag any specific supply issue. Shortage information on the FDA’s list is mostly provided by drug manufacturers.
For Lilly’s part, the company spokesperson cautioned that while wholesalers have built up investory, it may take time for some pharmacies to get back to full stocking based on the distribution chain. Besides, some people may still need to wait one to two day for Mounjaro based on each phamacy's stocking.
Mounjaro landed on FDA’s limited supply radar in mid-December, about half a year after its FDA approval in type 2 diabetes. Back then, only the 5mg/0.5mL dosing regimen was flagged as being in short supply. An update Tuesday shows all six presentations are available.
Demand for Mounjaro surged following impressive weight reduction data in an obesity trial. Supply constraints for Novo Nordisk’s rival diabetes and weight loss drugs, Ozempic and Wegovy, as well as a social media craze over these drugs, further fueled interest in Mounjaro. The Novo drugs are both made with the GLP-1 agonist semaglutide, while Mounjaro is tirzepatide, a dual GIP/GLP-1 agonist.
Novo’s 0.25mg/0.5 mg presentation of diabetes drug Ozempic is currently in limited supply, with full availability expected mid-March, according to the FDA.
Novo’s Wegovy is in a similar situation as Mounjaro. The Novo obesity drug recently resolved a supply issue, even though it’s still listed as in shortage by the FDA as of January.
Lilly’s own GLP-1 drug, Trulicity, is also in short supply. The FDA’s system currently says pharmacies may experience delays in receiving full shipments of the two higher doses of Trulicity through April. The drug has two other doses available.
Lilly has tried several approaches to cope with the supply challenge. It has promised to prioritize access for Type 2 diabetes patients over off-label weight-loss uses. In addition, the company in January unveiled a $450 million investment in its Research Triangle Park plant in North Carolina to boost output for Mounjaro. The company aims to double its capacity to produce Trulicity and Mounjaro by the end of 2023.
The expansion efforts also come as Mounjaro’s proposed use to reduce weight has gained an FDA “fast track” designation. As Lilly looks to wrap up a second weight management trial soon, the company expects an FDA application and approval this year, which would likely trigger another spike in demand.
Editor's Corner: The story have been updated with additional comments from a Lilly spokesperson.