Replies to post #246072 on Biotech Values

[DewDiligence]

NVO reports Rybelsus* data for non-diabetic obese patients:

https://www.globenewswire.com/news-release/2023/05/22/2673552/0/en/Novo-Nordisk-A-S-Oral-semaglutide-50-mg-achieved-15-1-weight-loss-17-4-if-all-people-adhered-to-treatment-in-adults-with-obesity-or-overweight-in-the-OASIS-1-trial.html

Novo Nordisk today announced headline results from OASIS 1, a phase 3a trial in the global OASIS programme. OASIS 1 is a 68-week, efficacy and safety trial comparing once-daily oral semaglutide 50 mg for weight management to placebo in 667 adults with obesity or overweight with one or more comorbidities. Both treatment arms were in conjunction with lifestyle intervention. The trial achieved its primary endpoint by demonstrating a statistically significant and superior weight loss at week 68 with oral semaglutide 50 mg versus placebo.

When evaluating the effects of treatment if all people adhered to treatment1 from a mean baseline body weight of 105.4 kg, people treated with oral semaglutide 50 mg achieved a statistically significant weight loss of 17.4% after 68 weeks compared to a 1.8% reduction with placebo. In addition, 89.2% of those who received oral semaglutide 50 mg, reached a weight loss of 5% or more after 68 weeks, compared to 24.5% with placebo.

…Novo Nordisk expects to file for regulatory approval in the US and the EU in 2023. The global launch of oral semaglutide 50 mg is contingent on portfolio prioritisations and manufacturing capacity.

Emphasis added. NVO has been unable to manufacture Wegovy in sufficient quantity, which is presumably the reason for the caveat in the bottommost sentence.

*Rybselsus is NVO’s brand name for oral semaglutide in the T2D indication. It’s possible that a different brand name will be used if the same product is approved for obesity, which is why the above PR does not reference the name, Rybelsus. Please see #msg-171530263 for related info.