The European Medicines Agency (EMA) has approved the expanded employ of tirzepatide, marketed as Mounjaro, to include treatment for obesity and a specific type of heart failure, according to announcements made on February 16th and 17th, 2026.
The approval extends Mounjaro’s application beyond its existing authorization for type 2 diabetes, which is not satisfactorily controlled through diet and exercise. The EMA’s decision covers the treatment of obesity and heart failure with preserved ejection fraction (HFpEF) in adults. Clinical trial data demonstrated a 38% reduction in the risk of events related to heart failure, including hospitalizations or the need for intensified treatment, among patients treated with tirzepatide. The drug also led to a 56% reduction in hospitalization specifically for heart failure, alongside significant improvements in physical function and a 14% reduction in body weight over 52 weeks of therapy.
The trials, conducted across ten countries but not including Spain, involved 731 participants and utilized weekly injections of tirzepatide at doses of five, ten, and fifteen milligrams, alongside a placebo. The study was designed as a multicenter, randomized, double-blind, parallel-controlled trial to assess the impact of the drug on mortality, cardiovascular events, and physical limitations associated with heart failure, with a follow-up period of 104 weeks.
Mounjaro is an agonist of the glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptors. While already approved by the Spanish Ministry of Health for type 2 diabetes, it is not currently covered by the national health insurance system, unlike semaglutide, the active ingredient in Ozempic, which also treats obesity and diabetes. In 2024, Spain’s public health system spent 403 million euros on prescriptions for semaglutide, with demand increasing by approximately 40% annually over the past three years.
Discussions are currently underway between pharmaceutical company Lilly and Spanish health authorities regarding potential public funding for Mounjaro, though no immediate commitment has been made. The EMA’s approval now expands the potential patient base for the drug to include individuals with obesity, even in the absence of other comorbidities, and those suffering from HFpEF.
