Four Doses of Lilly’s Mounjaro Will Be in Short Supply Through April 2024: FDA

Eli Lilly_iStock, jetcityimage

Pictured: Eli Lilly's world headquarters in Indianapolis/iStock, jetcityimage

Multiple doses of Eli Lilly’s top-selling diabetes medication Mounjaro (tirzepatide) will be in short supply through April 2024, according to the FDA’s database for drug shortages and discontinuations.

Mounjaro’s 7.5-mg, 10-mg, 12.5-mg and 15-mg dose strengths will have limited availability throughout the month, according to the FDA. The shortage is due to a spike in the demand for the diabetes therapy. The availability of Mounjaro’s lower dose levels—5-mg and 2.5-mg—will not be impacted.

The regulator’s update on the Mounjaro shortage follows a previous notice by the FDA in February 2024, in which it announced that the three highest dose levels of the medication would be in short supply. According to reporting by Reuters, Lilly at the time expected that it would need until early March 2024 to address back orders for the 10-mg, 12.5-mg and 15-mg doses of Mounjaro.

A Lilly spokesperson in a statement to Fierce Pharma pointed to the “unprecedented demand” for Mounjaro as the reason for the shortage, adding that the company is “moving with purpose and urgency to ensure our innovations are available to those who need them.”

Mounjaro’s active ingredient is tirzepatide, a GLP-1 receptor agonist that mimics the GLP-1 hormone to induce the secretion of insulin from the pancreas in response to blood sugar level. Mounjaro is indicated for the treatment of type 2 diabetes, for which it won approval in May 2022. However, it has been used on an off-label basis for chronic weight management.

In November 2023, the FDA formally approved tirzepatide for the treatment of obesity, for which it carries the brand name Zepbound.

Currently, Lilly shares the lucrative obesity market with Novo Nordisk whose GLP-1 receptor agonist semaglutide is also indicated for type 2 diabetes as Ozempic, and for weight management as Wegovy. Analysts expect the two companies to capture the vast majority of the obesity space, which in the coming years could reach up to $200 billion in value.

Both Lilly and Novo have struggled to keep up with the market’s insatiable appetite for obesity treatments.

To bolster its supply capacity, Lilly in November 2023 invested $2.5 billion to build a manufacturing facility in Germany, focusing on the production of its diabetes and obesity products. The plant will allow Lilly to hire an additional 1,000 skilled workers, such as engineers, operators and scientists. Construction for this facility is scheduled to begin this year.

Lilly also revealed in its fourth-quarter 2023 earnings report in February 2024 that it was making additional investments in its manufacturing capacity to prepare for the company’s next-generation oral weight-loss therapy orforglipron.

Novo has worked to improve its semaglutide supply with the $16.5 billion acquisition of CDMO giant Catalent, a $6 billion boost to its manufacturing capacity in Denmark and a $556 million contract to expand its sterile preparations operations in China.

Tristan Manalac is an independent science writer based in Metro Manila, Philippines. Reach out to him on LinkedIn or email him at tristan@tristanmanalac.com or tristan.manalac@biospace.com.

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