FDA Reports Extended Shortages for Eli Lilly’s Diabetes Drug Mounjaro

The U.S. Food and Drug Administration (FDA) announced that shortages of Eli Lilly’s diabetes medication, Mounjaro, specifically its higher doses, will persist until May, with an additional lower dose also now facing limited availability. The affected doses include the 7.5, 10.0, 12.5, and 15.0 mg versions, all experiencing constrained supply due to surging demand. This extension follows an earlier forecast predicting supply issues would be resolved by early March. However, Mounjaro’s 2.5 mg and 5 mg doses remain accessible.

Eli Lilly, in its latest financial disclosure, acknowledged ongoing intermittent delays in fulfilling orders for certain doses of Mounjaro, attributing these challenges to the drug’s significant demand. This demand is partly driven by the off-label use of Mounjaro for weight loss, in addition to its primary indication for treating type 2 diabetes. Mounjaro is also approved under the name Zepbound for weight loss purposes.

To address these shortages and meet the escalating demand, Eli Lilly is expanding its manufacturing capabilities. The company is enhancing its production facility in Research Triangle Park, North Carolina, and advancing manufacturing at two sites within Indiana’s LEAP Innovation Park. Furthermore, a $2.5 billion investment is directed towards a new facility in Germany aimed at expanding Eli Lilly’s global injectable and device manufacturing network, signifying the company’s commitment to resolving supply constraints and supporting patient needs.

To read more, click here.

[Source: Endpoints, April 2nd, 2024]