Novo Nordisk Reports Submission of Label Extension Application to the EMA for Semaglutide (once weekly, 2.0 mg) for T2D

December 30, 2020 Auto Bot EMA, Novo Nordisk, regulatory, reports, semaglutide, Submission 0

Shots:

  • The submission is based on SUSTAIN FORTE trial assessing Ozempic (2.0mg, qw) vs Ozempic (1.0mg) in 961 people with T2D in need of treatment intensification
  • Result: 2.0 mg of dose achieved significant and superior reduction in HbA1c @40wks., both the doses are safe and well-tolerated
  • Ozempic is a glucagon-like peptide-1 (GLP-1) analogue and is currently approved in the EU for 0.5 mg and 1.0 mg doses to treat T2D in adults

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