The FDA has issued a press release regarding the approval of the first oral GLP-1 treatment for type 2 diabetes. Novo Nordisk also issued a press release on Rybelsus®. Novo Nordisk in the US issued a separate press release. In terms of future peak sales this might be the most important FDA approval of any drug this year.
![](https://www.rybelsuspro.com/content/dam/novonordisk/rybelsuspro/NowApproved/Rybelsus_logo.png)
Insulin has in recent years lost market share to drugs such as injected GLP1, oral SGLT2 and in particular oral DPP4 such as Januvia® from Merck and Trajenta® from Eli Lilly.
![](http://midgardfinance.com/companies/N/NOVO-B.CO/2019Q2_diabetes_by_drug_type.png)
Novo Nordisk has annual sales of approximately $17B of which more than 80% originate from anti-diabetic drugs. The oral DPP4 drug Januvia® in 2016 reached worldwide peak sales of approximately $6B. Rybelsus® does not have the same side effects as DPP4 and it is not impossible imagining Rybelsus® reaching peak sales as high or higher than Januvia®. Sales of Victoza® and Levemir® will continue to shrink as they are cannibalised by their superior equivalents Ozempic® and Tresiba® and other drugs. But this deterioration will most likely be more than offset by Rybelsus® going forward.
![](http://midgardfinance.com/companies/N/NOVO-B.CO/2019Q2_by_drug.png)
The late stage clinical trial SOUL (NCT03914326) for oral semaglutide follows the phase 3 PIONEER studies. If this trial is succesful, then this could put Rybelsus® on par with other GLP1 class drugs in terms of major adverse cardiovascular events (MACE) and further boost sales of Rybelsus® in the decade ahead.
![](http://midgardfinance.com/companies/N/NOVO-B.CO/NOVO-B.CO2019Q2_slide13.png)
Additionally it is worth pointing out that injected semaglutide is already used for the treatment of obesity (Saxenda®) and oral semaglutide could very well be approved for the same purpose.
![](http://midgardfinance.com/companies/N/NOVO-B.CO/NOVO-B.CO2019Q2_slide11.png)
Novo Nordisk has with the approval of oral semaglutide for the treatment of type 2 diabetes (Rybelsus®) positioned itself well for the future. But the approval might have been expected by the market for the past few years and a lot of it might already be priced in as witnessed by the somewhat insignificant share price movement of approximately +2% following the approval.
![](https://www.midgardfinance.com/plot/price/N/NOVO-B.CO_pe_2010-01-01.png)
Reuters – Novo Nordisk wins U.S. approval for first-of-its-kind oral diabetes drug