The FDA has added Eli Lilly's diabetes medication, Mounjaro, to its drug shortage database as demand has increased.
The shortage of the supply of the 10mg dose is expected until September 2023, with the agency stating that its caused by heightened demand. Issues with supply with 7.5mg, 12.5mg, and 15mg doses are anticipated to be resolved by the end of July.
First approved in May of last year, Mounjaro (tirzepatide), is a first-in-class dual-action med that is injected once a week and activates glucose and insulin receptors in the body. Mounjaro belongs to an increasingly popular class of drugs, GIP/GLP-1 agonists, which work by targeting two hormones called glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide. The hormones play an important role in regulating blood sugar levels and appetite and trial data showed that patients on the highest dose of Mounjaro lost an average of 12 pounds more than those on Novo Nordisk’s blockbuster Ozempic.
Lilly recent shared impressive results from two phase 3 trials testing Mounjaro in overweight or obese patients without type 2 diabetes, teeing up a future approval for the drug in obesity — but it seems patients are not willing to wait on the approval.
GLP-1 agonists, which have been dominating headlines as celebrities and internet influencers sang their praises when used off-label as a weight loss drug, have been recently flagged by the EMA for possible suicide ideation and self-harming risk.