[CLSTR]
< Back to situations

Monitor this situation.

[SITUATION] · [QUIET] · [HEALTH]

2 clusters · 16 sources · 4 days · First seen · Last updated

FDA approval of Mounjaro for cardiovascular risk

Overview

The U.S. Food and Drug Administration (FDA) has approved Eli Lilly’s diabetes medication, Mounjaro (tirzepatide), to reduce the risk of major adverse cardiovascular events (MACE) in adults with type 2 diabetes who are at high risk. This approval covers the reduction of cardiovascular death, non-fatal heart attack, and non-fatal stroke.

The decision is based on the SURPASS-CVOT phase 3 clinical trial involving over 13,000 participants. In comparison to the older drug Trulicity (dulaglutide), Mounjaro demonstrated an 8% lower rate of MACE and a 16% reduction in deaths from any cause.

This regulatory expansion moves the drug’s clinical profile beyond glycemic and weight management into cardioprotection, intensifying competition in the GLP-1 market against manufacturers such as Novo Nordisk.

Entities

Novo Nordisk · FDA · Mounjaro · Roivant Sciences · Trulicity

Timeline

  1. 12 days ago

    [HEALTH] 3 sources
    FDA approves Eli Lilly's Mounjaro to reduce heart attack and stroke risk

    The FDA has approved Eli Lilly’s Mounjaro to reduce heart attack and stroke risks in adults with Type 2 diabetes and high cardiovascular risk, following successful clinical trials.

  2. 15 days ago

    [HEALTH] 14 sources
    Eli Lilly's Mounjaro receives FDA approval to reduce cardiovascular risk

    The FDA has approved Eli Lilly’s Mounjaro to reduce the risk of heart attack, stroke, and cardiovascular death in adults with type 2 diabetes, following successful SURPASS-CVOT clinical trials.

Sources

arynews.tv · bolnews.com · brasilemfolhas.com.br · capital.gr · consultantlive.com · finanzen.at · foreignpolicyjournal.com · gazetashneta.net · it-boltwise.de · medicaldaily.com · mononews.gr · nbcpalmsprings.com · ohoje.com · pharmabiz.net · sbctv.gr · upday.com