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Tirzepatide Approved in US as “Mounjaro”
FDA announced it has approved Lilly’s tirzepatide as “Mounjaro” for the treatment of adults with T2DM. Recall, Lilly filed the tirzepatide T2DM BLA with a PRV in October 2021 (previous FENIX insight) which allowed for a 6-month review. Tirzepatide remains under review in the EU. The label has not yet been observed at the time of this publication. FENIX will conduct a full label analysis of tirzepatide in the coming days once the label is available.