By Fineline Cube 
Eli Lilly (NYSE: LLY) announced that the European Medicines Agency (EMA) drug advisory panel declined to recommend approval for Mounjaro (semaglutide) for treating heart failure with preserved ejection fraction (HFpEF) in adults with obesity. The panel concluded it remains uncertain whether the reduction in heart‑failure hospitalizations reflects a weight‑loss‑independent effect of Mounjaro.
Regulatory Outcome & Clinical Context
| Item | Detail |
|---|---|
| Company | Eli Lilly (NYSE: LLY) |
| Drug | Mounjaro (semaglutide) |
| Indication | HFpEF with obesity |
| Regulatory Body | EMA drug advisory panel |
| Outcome | Approval denied |
| Reason | Uncertainty about weight‑loss‑independent effect |
| Data Inclusion | Study data to be included in product information |
| Clinical Trial | HFpEF obesity trial showing hospitalization reduction |
Market Impact & Commercial Outlook
- HFpEF Market: EU HFpEF market projected at $1.2 billion : by 2028; loss of indication limits Mounjaro’s expansion beyond obesity and diabetes
- Weight‑Loss Framing: Panel’s decision emphasizes that cardioprotective benefits may be secondary to weight loss, challenging Lilly’s cardiovascular strategy
- Revenue Impact: Analysts estimate EU HFpEF indication could have added $500 million–800 million in peak sales; denial represents a 2–3% downside to Lilly’s 2026 revenue guidance
- Competitive Landscape: Novo Nordisk’s Wegovy faces similar scrutiny; Boehringer Ingelheim/Eli Lilly’s Jardiance remains standard of care for HFpEF
- Stock Reaction: Shares down ~4% : in pre‑market trading as investors recalibrate cardiovascular growth expectations
- Strategic Pivot: Lilly will focus on obesity and diabetes indications while exploring additional cardiovascular outcome trials to prove weight‑loss‑independent effects
Forward‑Looking Statements
This brief contains forward‑looking statements regarding commercial expectations, market growth, and regulatory pathways for Mounjaro. Actual results may differ due to competitive dynamics, evolving regulatory interpretations, and clinical trial outcomes.-Fineline Info & Tech