Novo Nordisk’s Rybelsus (semaglutide) Receives FDA’s Approval as the First Oral GLP-1 analog for Type 2 Diabetes

Novo Nordisk Reports Cardiovascular Outcomes of Oral Semaglutide in PIONEER 6 Study for Type 2 Diabetes


  • The FDA’s approval is based on 10 PIONEER clinical studies assessing Rybelsus vs sitagliptin, empagliflozin and liraglutide in 9,543 patients with T2D as an adjunct to diet & exercise
  • The clinical studies resulted in A1C reduction as 1EPs & reduction in body weights as 2EPs. Additionally, in H1’19, Novo Nordisk acquired a tableting and packaging facility in Durham to meet anticipated supply needs for Rybelsus
  • Rybelsus (qd) is an oral glucagon-like peptide-1 (GLP-1) analog, approved in two therapeutic doses 7/14mg with its expected availability in the US in Q4’19 and is under EMA & PMDA’s review. The US FDA is also reviewing Ryblesus for an additional indication, reducing the risk of MACE with an expected decision in Q1’20

Click here to­ read full press release/ article | Ref: PRNewswire | Image: Novo Nordisk