Category Archives: SGLT2i

Lilly, Novartis, Pfizer, and Merck Q3 ’20 Earnings Updates

Lilly, Novartis, Pfizer, and Merck each hosted their respective Q3 ’20 earnings calls and provided updates across a variety of topics. Importantly, it was disclosed that FDA has requested an advisory committee meeting to discuss Novartis’s Entresto PARAGON-HF submission. Below, FENIX provides highlights and insights from the respective earnings calls.

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FIDELIO Demonstrates 18% RRR; DAPA-CKD and EMPEROR-Reduced Sub-Analyses

On the second day of Kidney Week 2020, three notable data sets were released: Bayer’s FIDELIO-DKD study demonstrated an 18% RRR in the primary composite endpoint (view press release; view NEJM publication); AstraZeneca presented a DAPA-CKD sub-analysis that demonstrated a reduction in the composite endpoint irrespective of the underlying CKD cause (view press release); BI/Lilly presented an EMPEROR-Reduced sub-analysis showing no difference in CV/renal outcomes regardless of baseline CKD (view press release). Below, FENIX provides highlights and implications of the data with a particular focus on FIDELIO.

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New AZD9977 + Dapa Ph2b Trial in HF+CKD (MIRACLE)

A CT.gov record has been observed for a new Ph2b trial evaluating AZD9977, a novel mineralocorticoid receptor modulator (MCR), as add-on to dapagliflozin in patients with HF and CKD. The trial initiation is in-line with AZ’s commentary from its Q2 ’20 earnings call (previous FENIX insight). Of note, John McMurray is the PI for the MIRACLE trial. McMurray previously served as the PI for DAPA-HF and a member of the executive committee for DAPA-CKD. Below, FENIX provides an overview of the MIRACLE trial as well as why AZ’s pursuit of accelerated approval for AZD9977 could make sense.

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DAPA-HF Receives Positive CHMP Opinion; Oramed Oral Insulin Ph3 T2DM Development Update; Livongo Partners with GuideWell

Three diabetes-related news items have been observed: DAPA-HF received a positive CHMP opinion (view here); Oramed announced it has come to an agreement with FDA regarding the Ph3 T2DM program design for its oral insulin (ORMD-0801), with the company planning to initiate the trials in Q4 ’20; and Livongo has partnered with Guidewell (Florida Blue) to expand access to Livongo’s Diabetes platform in Florida. As of this publication, an AstraZeneca press release regarding the DAPA-HF CHMP opinion has not been observed. Below, FENIX provide highlights and insights for the respective news items.

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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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