Eli Lilly's Mounjaro shortage worsens ahead of potential obesity FDA approval

As with Novo Nordisk’s popular offering for obesity, Wegovy, demand for Eli Lilly’s dual GIP/GLP-1 agonist Mounjaro appears to be outpacing supply once again.

The U.S. Food and Drug Administration has added a fourth dose of Lilly’s popular new diabetes med to its drug shortage database. The agency also expects supply issues with three other doses to persist longer than previously thought.

The reason listed for the supply squeeze is a demand increase. Now, supplies of Mounjaro at the 10mg dose are expected to be tight through September 2023. Issues with the 7.5mg, 12.5mg and 15mg doses are expected to be resolved by the end of July.

Lilly did not immediately respond to Fierce Pharma’s request for comment on the situation. A company spokesperson confirmed the updates to the FDA’s website in comments to Bloomberg. The spokesperson also pointed out that Lilly is pumping cash into expanded manufacturing capacity for its drug.

After scoring an approval in type 2 diabetes last May, Lilly’s Mounjaro has generated substantial hype, especially for its potential as a weight loss medication. Lilly won an FDA fast-track designation for a potential obesity nod in October and has been furnishing the regulator with data from its Surmount-1 and Surmount-2 trials on a rolling basis.

In April, Mounjaro passed its second obesity study, Surmount-2, with flying colors. In the study, the med helped patients who are obese or overweight lose up to 15.7% of their body weight.

But even as Lilly inches toward a potential obesity approval, the company and its rival Novo Nordisk have been struggling with shortages of their metabolic medicines for months.

In Lilly’s case, supplies of the diabetes medicines Trulicity and Mounjaro both started to run scarce in the U.S. in December, according to the FDA’s online drug shortage database. At the time, the FDA credited the Mounjaro shortfall to the “dynamic nature of this new product launch.”

By February, Lilly said it had satisfied wholesalers’ backorders for Mounjaro and that it was continually shipping all six doses of the new diabetes med. 

Lilly apparently slipped back into constrained supply for Mounjaro in June, when the FDA updated its drug shortage list to include “intermittent back orders” for three of six dosing strengths through the middle or end of July.

Novo has likewise experienced stocking issues with its obesity med Wegovy and its semaglutide cousin for type 2 diabetes, Ozempic. Those supply constraints recently extended to the Danish drugmaker’s weight loss predecessor Saxenda, too.

Both companies have been investing heavily in capacity expansions. Lilly in April said it would add $1.6 billion in investments to its new manufacturing sites in the LEAP Innovation Park in Boone County, bringing the total commitment there to $3.7 billion, the biggest single-site investment in the company’s history.

And in late 2021, Novo unveiled a $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 $2.3 billion to expand manufacturing at its API site in Hillerød, Denmark, to enable the production of future medicines.

Supply hitches aside, industry watchers have pinned high hopes on the obesity market. In late May, a report from Bloomberg Intelligence suggested sales of branded anti-obesity drugs could hit $44 billion in 2030.