Tag Archives: Diabetes

New Dexcom Pediatric TV DTC Campaign

A new Dexcom G6 CGM TV commercial called, “Diabetes Didn’t Come Up,” has recently been observed. Of note, this is believed to be the first time that Dexcom has created a commercial solely focused on the G6 CGM pediatric indication. Below, FENIX provides analysis of the messaging used in the TV commercial, thoughts on why the pediatric TV DTC hasn’t occurred until ~2 years after launch, and Dexcom’s peds positioning vs. Abbott Libre.

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Sanofi Bs-Aspart Receives Positive CHMP Opinion; No Update on CREDENCE

According to the CHMP meeting highlights, Sanofi’s bs-aspart has received a positive CHMP opinion. Of note, the Invokana/Vokanamet renal protection indication (CREDENCE) was not mentioned in the meeting highlights, suggesting additional questions were asked to the sponsor. Below, FENIX provides brief thoughts on the positive CHMP opinion for Sanofi’s bs-aspart.

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Roche mySugr Pro Free During COVID-19 Pandemic

Roche announced it is offering free access to mySugr Pro as part of an effort to improve remote diabetes management during the COVID-19 pandemic. According to Roche, free access to mySugr Pro will be granted through September 20, 2020. Below, FENIX provides brief thoughts on Roche’s COVID-19 response and how it appears to be a play for lead generation.

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CREDENCE and Sanofi’s Bs-Aspart up for CHMP Opinion; CHMP Agenda April 28-30

The CHMP agenda for this month’s meeting (April 28-30) has been released, and it includes two notable items up for CHMP opinion: Invokana/Vokanamet renal protection indication (CREDENCE) and Sanofi’s bs-aspart initial application. Of note, the April 2020 CHMP meeting agenda was just posted today despite the fact that the meeting started yesterday. Below, FENIX provides diabetes-related highlights and insights from the April 2020 CHMP agenda.

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AZ CVRM Q1 ’20 Earnings Update

AstraZeneca hosted its Q1 ’20 earnings call and briefly discussed its diabetes business including the recent topline data readout from DAPA-CKD, which stopped early for overwhelming efficacy. Interestingly, AZ said it does not project DAPA-CKD filing acceptance until 2021. Below, FENIX provides highlights and insights from the call, including thoughts on why the DAPA-CKD submission is later than expected.

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Ertugliflozin Fails to Demonstrate CV Benefit; Merck and Pfizer Q1 ’20 Earnings Updates

Merck and Pfizer hosted their respective Q1 ’20 earnings calls and provided updates to their diabetes businesses. Importantly, Merck disclosed that the VERTIS CV outcomes trial failed to meet superiority for CV protection. Full results from VERTIS CV are scheduled to be presented during the virtual ADA conference on June 16 at 11:15 AM ET. Below, FENIX provides highlights and insights from the respective earnings calls including thoughts on the surprising VERTIS CV results.

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Lexicon to Focus on Sota T1DM and Deprioritize T2DM; Lexicon Q1 ’20 Earnings Update

Lexicon hosted its Q1 ’20 earnings call and provided updates to the sotagliflozin business, including plans to focus on the sotagliflozin T1DM indication rather than T2DM. Recall, in March 2020 Lexicon announced the close out of the SCORED and SOLOIST outcomes studies due to COVID-19 as well as the low near-term prospect of finding a commercialization partner (previous FENIX insight). Below, FENIX provides highlights and insights from the call.

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Efpeglenatide Officially Removed From Sanofi Pipeline; Sanofi Q1 ’20 Earnings Update

Sanofi hosted its Q1 ’20 earnings call and provided a brief update to its diabetes business, including the official removal of efpeglenatide from Sanofi’s pipeline. Unsurprisingly, the vast majority of the call was dedicated to Sanofi’s COVID-19 response and the Dupixent performance. Below, FENIX provides highlights and insights from the call.

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Adocia Pramlintide+Insulin Positive Ph1b Topline Results

Adocia announced positive results of a Ph1b study of its pramlintide+human insulin fixed-ratio combination, also called M1Pram or ADO09. Adocia is planning to host a webcast (in French) on Monday, April 27 at 12pm ET to further discuss the results. Below, FENIX provides highlights of the results and insights in the context of Xeris’s pram-insulin which is currently in Ph2 development.

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Empa T1DM Discontinued; Lilly Q1 ’20 Earnings Update; AZ Initiates Farxiga COVID-19 Trial

Lilly hosted its Q1 ’20 earnings call and provided updates to its diabetes business. Of note, Lilly disclosed that the empa T1DM program has been discontinued. Separately, AstraZeneca announced plans to evaluate Farxiga as a treatment for hospitalized COVID-19 patients who are at increased risk of complications, such as organ failure. The trial is being conducted at Saint Luke’s Mid America Heart Institute and led by Mikhail Kosiborod. Below, FENIX provides highlights and insights from the Lilly earnings call as well as thoughts on the new AZ trial.

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