The European Medicines Agency’s Committee for Medicinal Products for Human Use approved the extension of Eli Lilly’s tirzepatide (Mounjaro) to patients aged 10 and older, a decision that will allow the drug to be prescribed under EU national health‑insurance schemes for pediatric type‑2 diabetes.
The approval follows the SURPASS‑PEDS trial, which showed a 2.2 percentage‑point reduction in HbA1c and an 11.2% decrease in BMI at the 10 mg dose compared with placebo, confirming the drug’s safety and efficacy in children and adolescents.
Eli Lilly’s Q3 2025 revenue reached $17.60 billion, a 54% year‑over‑year increase driven largely by Mounjaro and the recently launched weight‑management drug Zepbound. The two products together generated $10.1 billion in sales, up from $4.37 billion in Q3 2024, and the company raised its full‑year 2025 revenue guidance to $63 billion–$63.5 billion.
The pediatric approval expands Mounjaro’s addressable market, potentially adding a substantial new revenue stream and reinforcing Lilly’s leadership in the GLP‑1 and diabetes therapeutic area. It also strengthens the company’s competitive position against rivals such as Novo Nordisk, whose Ozempic and Wegovy products dominate the adult market.
The decision aligns with Lilly’s broader strategy of leveraging its dual GIP/GLP‑1 mechanism to capture high‑margin growth opportunities. Management has highlighted the strong performance of its core incretin portfolio and the company’s confidence in sustaining revenue growth through continued product expansion.
Overall, the EMA endorsement signals regulatory confidence in Mounjaro’s pediatric profile and positions Eli Lilly to capitalize on a growing segment of type‑2 diabetes patients, while reinforcing its market leadership in the rapidly expanding GLP‑1 space.
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