EU Rejects Lilly's Heart Failure Heartbreak

Eli Lilly & Co. has faced a setback as the European Union's medicines regulator declined to endorse its weight-loss drug, Mounjaro, for treating a specific form of heart failure in adults with obesity. The European Medicines Agency's drug advisory panel on Friday stated it remains uncertain if the trial's observed reduction in heart-failure hospitalizations was due to a mechanism separate from weight loss.

This decision impacts Lilly's strategy to expand the patient pool for its highly successful medication, known as Zepbound in the US. The pharmaceutical industry is actively seeking to broaden insurance coverage for weight-loss drugs by demonstrating their efficacy beyond weight reduction, highlighting improvements in various health components.

Although a distinct indication was not recommended, the EMA agreed to incorporate the study's relevant findings into Mounjaro's product information. The trial focused on patients with heart failure with a preserved ejection fraction (HFpEF), a condition strongly associated with obesity affecting millions globally and carrying a significant mortality rate.

Lilly's two-year trial, involving over 700 participants, indicated that Mounjaro significantly improved the long-term health of these patients. The study demonstrated a 38% reduction in risks such as death and hospitalization compared to a placebo, along with notable improvements in heart failure symptoms like shortness of breath and fatigue. The EMA acknowledged the drug's impact on hospitalizations but noted that Mounjaro is already approved for weight management, covering its use in this patient group.