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

 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

Shots:

  • 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

Tuba Khan

Tuba Khan is Senior Editor at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in the Life sciences industry. She covers Biopharma, MedTech, and Digital health segments. Tuba also has an experience of digital and social media marketing and runs the campaigns independently. She can be contacted on tuba@pharmashots.com

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