Summary of Cancellation for Mounjaro

The purpose of this Supplement to a New Drug Submission was to expand the conditions of use of Mounjaro (tirzepatide) by adding a new indication for the reduction of the risk of worsening heart failure and the improvement of clinical symptoms and functional capacity in adults with obesity and heart failure with preserved ejection fraction.

The manufacturer submitted a clinical data package and revised labelling. The submission was reviewed using the international review work-sharing model within the Access Consortium. Swissmedic led the review of the clinical module, and Health Canada and the Australian Therapeutic Goods Administration peer-reviewed it.

The safety and efficacy of Mounjaro in adults with obesity and heart failure with preserved ejection fraction was evaluated in a single Phase 3 international, randomized, double-blind, placebo-controlled study (SUMMIT). A total of 364 participants received tirzepatide and 367 received placebo weekly for at least 52 weeks. The two primary efficacy endpoints were: change from baseline to Week 52 in the Kansas City Cardiomyopathy Questionnaire-Clinical Summary Score and the composite of cardiovascular death or heart failure events over time.

At the time of the cancellation, the review of the submission was nearing completion. All three agencies had identified deficiencies in the data and did not consider the safety data provided to be sufficient to support market authorization for this indication The manufacturer chose to cancel the submission.

There is no expected impact for patients using SAP or in clinical trials. The drug remains authorized for its approved indications.