USA —Eli Lilly’s diabetes medication, Mounjaro has been surging in popularity, particularly for its potential as a weight loss medication, akin to Novo Nordisk’s acclaimed obesity offering, Wegovy.
However, demand for Mounjaro has once again outpaced supply, leading to concerns about its availability.
The U.S. Food and Drug Administration (FDA) has recently added a fourth dose of Mounjaro to its drug shortage database, while expecting supply issues with three other doses to persist longer than initially anticipated.
The primary reason cited for this supply crunch is the tremendous increase in demand. As a result, Mounjaro at the 10mg dose is expected to remain scarce until September 2023.
Meanwhile, the issues with the 7.5mg, 12.5mg, and 15mg doses are projected to be resolved by the end of July. In response to the situation, Lilly has been investing in expanding its manufacturing capacity for the drug.
Mounjaro’s journey has been one of great anticipation since its approval for type 2 diabetes last May. Its potential as a weight loss medication has sparked significant hype, and the FDA granted it a fast-track designation for potential approval in obesity treatment in October.
Lilly has been diligently providing the regulator with data from its Surmount-1 and Surmount-2 trials on an ongoing basis.
In April, Mounjaro cleared its second obesity study, Surmount-2, with flying colors. The medication showcased its ability to help obese or overweight patients lose up to an impressive 15.7% of their body weight.
Despite these positive developments, both Lilly and its competitor Novo Nordisk have been grappling with shortages of their metabolic medicines for several months.
Lilly’s diabetes medicines, Trulicity and Mounjaro, experienced scarcity in the U.S. in December, attributed to the dynamic nature of Mounjaro’s new product launch.
In February, Lilly addressed the shortages and fulfilled wholesalers’ backorders for Mounjaro. However, the constrained supply reemerged in June, as intermittent back orders affected three of its six dosing strengths.
Novo Nordisk has also encountered stocking challenges with its obesity medication Wegovy, its semaglutide-based diabetes treatment Ozempic, and its weight loss predecessor, Saxenda.
Both companies have been making substantial investments in expanding their manufacturing capacities to meet the burgeoning demand for their metabolic medications.
Lilly in April said it would add US$1.6 billion in investments to its new manufacturing sites in the LEAP Innovation Park in Boone County, bringing the total commitment there to US$3.7 billion, the biggest single-site investment in the company’s history.
And in late 2021, Novo unveiled a US$2.58 billion plan to build three new manufacturing plants and expand its sprawling site in Kalundborg, Denmark, mostly to increase capacity for active pharmaceutical ingredients (API).
In June, the company pledged another US$2.3 billion to expand manufacturing at its API site in Hillerød, Denmark, to enable the production of future medicines.
Despite the supply hitches, industry experts remain optimistic about the potential of the obesity market.
A report from Bloomberg Intelligence projects that sales of branded anti-obesity drugs could soar to a staggering US$44 billion by 2030.
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