Category Archives: SGLT2i

Dario Included in Vitality’s Gateway Flex Program; J&J Q3 ’20 Earnings Update

Dario announced it has been chosen for inclusion in Vitality’s new Gateway Flex offering. J&J also hosted its Q3 ’20 earnings call (press release; slides), and unsurprisingly, there was significant discussion surrounding the recent pause on J&J’s COVID-19 vaccine trial due to an unknown illness in one of the trial participants (view statement from J&J). Below, FENIX provides insight into the impact of Gateway Flex on Dario’s business as well as diabetes-related financial highlights from the J&J earnings call.

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DAPA-HF CHMP Opinion This Week?; October 12-15 CHMP Agenda

The CHMP agenda for this month (October 12-15) has been released, and it includes one notable item, DAPA-HF, as well as several other agenda items. Below, FENIX provides diabetes-related highlights and insights from the October 2020 CHMP agenda.

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First Results for Bayer’s FIDELIO @ Kidney Week; ASN High-impact Trials Released

On Friday Oct 9, ASN posted more sessions for Virtual Kidney Week. Importantly, Bayer’s FIDELIO-DKD trial for finerenone will seemingly have first results presented during Kidney Week, rather than at Virtual AHA (previous FENIX insight). Below, FENIX provides a bit more detail and thought on a dynamic 3-4 weeks between Kidney Week and AHA.

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Sotagliflozin, Finerenone, and Omecamtiv CVOTs @ AHA 2020

The AHA 2020 late-breaking abstract titles have been published and include the sotagliflozin (SOLOIST-WHF and SCORED), finerenone (FIDELIO-DKD), and omecamtiv mecarbil (GALACTIC-HF) CVOTs (view all AHA late-breaking topics here). Recall, Bayer announced positive topline results from FIDELIO-DKD in July 2020 (previous FENIX insight). Lexicon has not released any topline results from the SOLOIST-WHF and SCORED trials, which were closed out early following the Sanofi partnership dissolution (previous FENIX insight). As such, the SCORED and SOLOIST-WHF results are highly anticipated.

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Senseonics Files 180-Day Implantable CGM sPMA; Beyond Type 1 Launches Insulin Affordability Resource; KDIGO Releases New 2020 T2DM+CKD Guidelines

A series of diabetes-related news items have been observed: Senseonics announced the sPMA filing of its 180-day implantable CGM; Beyond Type 1 launched GetInsulin.org as a tool to connect PWD to insulin assistance programs and low-cost insulin solutions (press release); and Kidney Disease: Improving Global Outcomes (KDIGO) recently released its first-ever T2DM CKD guidelines, called 2020 Clinical Practice Guideline for Diabetes Management in CKD (view press release; view complete document here). Below, FENIX provides highlights and insight from the respective news items.

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Farxiga Receives Breakthrough Therapy Designation for CKD

AstraZeneca announced FDA granted Breakthrough Therapy Designation (BTD) to Farxiga for the treatment of chronic kidney disease in patients with and without diabetes. Below, FENIX provides thoughts on the impending DAPA-CKD regulatory review in the context of Janssen’s CREDENCE and readthrough to BI/Lilly’s EMPA-KIDNEY.

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Dexcom Publishes G6 UK Cost-Effectiveness Data and Launches G6 in Turkey; Lifescan Launches OneTouch Amazon Storefront; Daewoong Pharma Announces Ph2 Results for Enavogliflozin; Zucara Therapeutics Doses First Patient in Preventative Hypo Study

A series of diabetes-related news items have been observed: Dexcom published results from a study evaluating the cost-effectiveness of its G6 CGM in the UK and announced the launch of G6 in Turkey; Lifescan announced the launch of its OneTouch Amazon storefront; Daewoong Pharmaceutical announced the results of a Ph2 trial evaluating enavogliflozin; and Zucara Therapeutics announced the first patient has been dosed in a Ph1 trial of ZT-01 for insulin-induced hypoglycemia. Below, FENIX provides highlights and insights for the respective news items.  

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New Semaglutide HFpEF Trial (STEP HFpEF); DAPA-MI Posted on CT.gov; Final Day of EASD 2020 (Sept 25)

On the final day of EASD 2020, no new press releases were observed; however, during the Novo Nordisk obesity session, the speaker disclosed plans to conduct a semaglutide HFpEF study. Additionally, AstraZeneca’s DAPA-MI study has been posted on CT.gov. Below, FENIX provides insights and context from the respective news items, including thoughts on why the STEP HFpEF trial appears to fit into the new paradigm of non-outcomes-based label-enabling studies.

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Apple Cites T1DM Omnipod Patient Story at Tuesday Event; Jardiance Post-MI Trial (EMPACT-MI) Receives FDA FTD; Adocia Topline Results from M1Pram Ph1b Trial Extension; Welldoc/UMD Employs AI to Identify Digital Health Habits; Oramed’s Positive Diabetes Market Survey Results; Diamyd Receives $13.9M Towards Companion Medical Shares

A series of diabetes-related news items have been observed: Apple featured a T1DM patient story during the Apple Watch portion of its event; BI/Lilly announced Jardiance has received Fast Track designation for its EMPACT-MI study; Adocia announced positive topline results from its Ph1b M1Pram extension study in PWT1D; Welldoc and the University of Maryland’s Center for Health Information and Decision System (CHIDS) announced findings from a user engagement analysis; Oramed announced results from a diabetes market survey; and Diamyd received $13.9M from its divestment in Companion Medical. Below, FENIX provides highlights and insights from the respective news items.

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