Novo Nordisk publishes Phase III basis for oral semaglutide filing

25 March 2019

Shortly after announcing its US filing for oral semaglutide, Danish diabetes giant Novo Nordisk (NOV: N) has published positive Phase III data for the glucagon-like peptide-1 (GLP-1) analog in the Journal of the American Medical Association (JAMA).

Last week the firm said it had cashed in a coveted priority review voucher to expedite review of the candidate, as a treatment for glycemic control and for cardiovascular risk reduction in adults with type 2 diabetes.

The US regulator is expected to provide a decision within six months. If approved, it will become the first ever marketed complex biologic administered in a patient-friendly pill format.

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