US filing for Ozempic label expansion
Novo Nordisk (NOV: N) has sought a label expansion application from the US Food and Drug Administration (FDA) for the existing marketing authorization for Ozempic (semaglutide), a once-weekly glucagon-like peptide-1 (GLP-1) analogue, to introduce a new dose of 2mg.
Ozempic is currently approved in the USA in 0.5mg and 1mg doses for the treatment of type 2 diabetes in adults and to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes mellitus and established cardiovascular disease.
This submission is based on the results from the SUSTAIN FORTE trial, which included 961 people with type 2 diabetes in need of treatment intensification.
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