Tag Archives: High-dose Rybelsus

Novo to Displace Metformin as 1L T2DM Treatment?; Zealand Presents Amylin Analog Data at ObesityWeek; JNJ Q3 ‘23 Earnings

Three cardiometabolic-related news items have been observed: Novo Nordisk initiated a Ph3 study evaluating high-dose oral sema vs. Jardiance and vs. metformin in T2DM (view CT.gov record); Zealand announced presentations of clinical and non-clinical results from its amylin analog (ZP8396) at ObesityWeek 2023 (previous FENIX insight); and Johnson & Johnson hosted its Q3 ‘23 earnings call (view press release; slides). Below, FENIX provides highlights and insights into the respective new items, including thoughts on how Novo may be trying to displace metformin as first-line treatment for T2DM.

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Positive High-Dose Oral Semaglutide Topline Results

Novo Nordisk announced positive topline results from the PIONEER PLUS trial (view CT.gov record) evaluating high-dose oral semaglutide (25mg and 50mg). Interestingly, Novo stated it anticipates filing the 25mg and 50mg oral semaglutide doses for regulatory approval in the US and EU in 2023 although the “global roll-out of the 25mg and 50mg doses is contingent on portfolio prioritizations and manufacturing capacity.” Below, FENIX provides an overview of the high-dose Rybelsus data as well as insight into Novo’s decision for launching the additional doses.

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