Novo Will Go After MACE Indication For Victoza Based On LEADER

Positive cardiovascular outcomes data for Victoza were outlined at ADA, and Novo Nordisk said it plans to file an sNDA with FDA seeking a broad indication to include reduction in major adverse cardiac events (MACE). The indication is different than the one Lilly is pursuing for Jardiance.

Novo Nordisk AS is preparing to file an sNDA with FDA and European regulators for the glucagon-like peptide-1 (GLP-1) agonist Victoza (liraglutide) this fall to incorporate new data highlighting the drug’s cardiovascular benefits.

The Danish diabetes specialist presented positive data from the LEADER cardiovascular outcomes trial, testing Victoza versus placebo in patients with diabetes at high-risk of cardiovascular events, at the American Diabetes...

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