The US Food and Drug Administration (FDA) has reaffirmed that Eli Lilly's widely used weight-loss and diabetes drugs, Zepbound and Mounjaro, are no longer in shortage.
This decision follows a re-evaluation of the drugs' supply chain and demand, signaling a critical turning point in addressing the nationwide need for these treatments.
FDA Ends Tirzepatide Shortage, Orders Halt to Compounded Versions
The announcement effectively halts the production of cheaper compounded versions of tirzepatide, the active ingredient in the drugs. While compounding pharmacies can legally manufacture alternatives during shortages, they must cease production once FDA-approved supplies meet demand.
The FDA has allowed a grace period for compliance, requiring state-licensed pharmacies to stop production by February 18 and outsourcing facilities by March 19.
Eli Lilly welcomed the decision, crediting its manufacturing team's efforts to ramp up production and ensure adequate supply.
A company spokesperson emphasized that all unapproved versions of the drugs must be removed from the market and urged patients to transition to FDA-approved medications.
Compounded versions of tirzepatide gained popularity during the shortage, especially among patients paying out-of-pocket for weight-loss treatments not covered by insurance.
However, the FDA's reaffirmation restricts their availability, sparking concerns from the Alliance for Pharmacy Compounding, CNN said.
The group questioned the completeness of the FDA's data, with CEO Scott Brunner cautioning that the issue might not be fully resolved.
This development follows a legal dispute between the FDA and the Outsourcing Facilities Association, a trade group for larger compounding pharmacies.
The group sued the agency in October, claiming the FDA's earlier decision was premature and based solely on Eli Lilly's assurances. The lawsuit was paused after the FDA agreed to reconsider, but its recent decision reaffirms the shortage's resolution.
Zepbound and Mounjaro Sales Boost Eli Lilly's Market Performance
The end of the shortage shifts the focus to ensuring safe and regulated access to these medications.
Compounded versions, while filling a gap during shortages, have faced criticism for potential safety risks.
Eli Lilly and Novo Nordisk, which produces a rival drug, Wegovy, have also pursued legal action against unregulated sellers of knockoff products.
Meanwhile, Wegovy remains in shortage, reflecting continued challenges in meeting the high demand for obesity treatments. Surveys show hundreds of thousands of patients are still using compounded versions of semaglutide, Wegovy's active ingredient, highlighting the ongoing supply crunch.
According to Yahoo, Eli Lilly's efforts to stabilize supply come as the company enjoys robust market performance. Zepbound and Mounjaro are forecasted to generate combined sales exceeding $57 billion by 2030.
Despite temporary stock fluctuations, Eli Lilly's shares have risen 30% this year.
While the FDA's decision curtails compounding, analysts predict a modest impact on prescription volumes by 2025.
For patients relying on compounded alternatives, the transition to FDA-approved medications marks a significant adjustment. The broader pharmaceutical landscape continues to evolve as demand for innovative weight-loss and diabetes treatments surges.
