Tag Archives: oral semaglutide

New Oral Sema Primary Prevention CVOT (ASCEND PLUS)

Novo Nordisk and Oxford have initiated a new Ph4 T2DM CVOT, called ASCEND PLUS, evaluating 14mg QD oral semaglutide in 20,000 primary prevention patients (view CT.gov record). Of note, the trial was initially discussed back in June 2021, but it was just posted to CT.gov (view article). Interestingly, the study is said to be conducted virtually with no physical sites and all interactions being conducted using “innovative patient-centred web-based technology, supplemented by telephone, video call contact and mailed letters.” Below, FENIX provides an overview of the study and will conduct an in-depth analysis in the coming days.

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Lilly Connected Pen Update; Novo Q1 ’21 Post-earnings Event; Provention Bio, BD, ICPT, and REGN Earnings Updates

A series of cardiometabolic-related news items have been observed: Lilly provided an update on its connected pen development, including the disclosure of the Tempo Smart Button (view press release); Novo Nordisk hosted its post-Q1 ’20 earnings event (see previous FENIX insight on Q1 ’21 Novo earnings from May 5); Provention Bio (press release), Becton Dickinson (press release), Intercept (press release; slides) and Regeneron (press release) hosted their respective CY Q1 ’21 earnings calls. Below, FENIX provides highlights and insights from the respective news items, including thoughts on BD’s decision to spin off its diabetes business.

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Novo/Gilead NASH PoC Data @ AASLD; Novo Q3 ’20 London Earnings Event

Novo Nordisk hosted its post-Q3 ’20 earnings event in London (see previous FENIX insight on Q3 ’20 Novo earnings from October 30). Below, FENIX provides highlights and insights from the Novo earnings call beyond what was discussed on October 30, including insight into the impending semaglutide NASH Ph3 program initiation and thoughts on the high-dose oral semaglutide approval timeline.

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Novo Launches the First Rybelsus Video DTC campaign; New Omnipod DTC from Insulet

Two new DTC commercials have recently been observed: Novo Nordisk launched a Rybelsus video DTC called “Wake Up” and Insulet initiated an Omnipod video DTC called “Simplify Life with Omnipod.” Of note, this is the first Rybelsus video DTC to be observed since the Rybelsus US approval in September 2019. Below, FENIX provides analyses for both of the DTC commercials, including insight into the ongoing Rybelsus launch.

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New Novo QW Insulin Icodec Data; Novo Updates Rybelsus Website; Dexcom G6 VA Pharmacy Distribution; Ascensia Partners to Accelerate Data Strategy; REWIND Canada Approval; Oramed ORMD-0801 NASH Data; EASD 2020 Key Press Releases (Sept 22)

On Day 2 of EASD, five key press releases and news items were observed from Novo Nordisk, Dexcom, Ascensia, Lilly, and Oramed. Below FENIX provides insights and context from each respective announcement.

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New Oral Sema High-Dose and Flexible Administration Ph1 Trials from Novo

Two new Ph1 trials for Novo Nordisk’s oral semaglutide have been observed on CT.gov. The first Ph1 trial (NCT04524832) is evaluating high-dose oral semaglutide (25mg and 50mg), and the second study (NCT04513704) is comparing flexible administration schedules in terms of the required food restriction. Below, FENIX provides an overview of both trials as well as insight into why each of the trials clearly fit into Novo’s strategy for its GLP-1RA franchise.

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Rybelsus and URLi Receive Positive CHMP Opinions

Two important positive CHMP opinions were received this week for Novo Nordisk’s Rybelsus and Lilly’s ultra-rapid lispro product (to be branded as Liumjev). Below, FENIX provides thoughts on the positive CHMP opinions including insight into the ongoing US FDA review of Lilly’s URLi.

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FENIX Analysis: Rybelsus Launch

Following the September 2019 Rybelsus approval, Novo Nordisk initiated a limited launch in October 2019 to specialists and high-prescribing PCPs. Even with the limited promotional support, Rybelsus appears to be off to a highly successful start, ahead of both Trulicity and Ozempic time-aligned launches. Below, FENIX has conducted a launch analysis, including early insights from NRx trends as well as an overview of both field and digital promotion materials.

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Novo has a PCSK9i; Novo Q3 ’19 Earnings Update

Novo Nordisk hosted its Q3 ’19 earnings call (press release) and provided updates to its diabetes business, including details on the Ozempic and Rybelsus launches, discontinuation of an oral GLP-1RA (OG2023SC) due to promising new formulations of oral semaglutide, and other pipeline activities. Of note, Novo disclosed that it is developing a PCSK9i compound for potential co-formulation with its other pipeline products. Below, FENIX provides highlights and insights from the call.

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Novo Hosts Post-approval Rybelsus Investor Call; Semaglutide HFpEF Study?

Novo Nordisk hosted an investor call to discuss the recent Rybelsus FDA approval (previous FENIX insight). Unsurprisingly, much of the investor call discussion centered around Rybelsus pricing and market access. Below, FENIX provides a Rybelsus pricing and website analysis as well as thoughts on Novo’s commentary regarding a potential semaglutide HFpEF study.

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