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Re: DewDiligence post# 243899

Friday, 03/24/2023 1:01:10 PM

Friday, March 24, 2023 1:01:10 PM

Post# of 257318
NVO—Rybelsus 25mg/50mg doses show statsig superiority to 14mg dose in HbA1c reduction and weight loss:

https://www.globenewswire.com/news-release/2023/03/24/2634147/0/en/Oral-semaglutide-25-mg-and-50-mg-demonstrate-superior-reductions-in-HbA1c-and-body-weight-versus-14-mg-in-people-with-type-2-diabetes-in-the-PIONEER-PLUS-phase-3-trial.html

This phase-3b trial tested much higher Rybelsus doses—25mg and 50mg qD—than the currently approved doses of 3mg, 7mg, and 14mg qD. It’s not surprising that the higher doses produced better efficacy, but the incremental efficacy came with a higher rate of GI side effects, according to the above PR.

Rybelsus is a daily oral med with the same active ingredient (semaglutide) as NVO’s (weekly) injected drugs, Ozempic and Wegovy. Rybelsius and Ozempic are approved for T2D only, while Wegovy is approved for weight loss. All three drugs have boxed warnings for thyroid cancer.

Additionally, a major drawback of Rybelsus is that patients must use a tightly specified fasting protocol for the drug to work properly without undue side effects.

Please see #msg-170010898 and #msg-170009357 for related info re PFE’s oral GLP-1 program.

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